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Mutation in BRCA1 and BRCA2

BRCA1/2 mutation

168 active trials select patients by BRCA1/2 mutation or a broader group, and 83 of them are recruiting. 15 FDA and 9 EU approvals name it.

Trials as of 2026-10-27. Seen most often in breast, ovarian, prostate, pancreatic.

Active trials by phase
Early Phase 1: 2 active trialsEarly 12Phase 1: 32 active trials132Phase 1/2: 19 active trials1/219Phase 2: 57 active trials257Phase 2/3: 1 active trials2/31Phase 3: 25 active trials325Phase 4: 1 active trials41N/A: 31 active trialsNo phase31
Trials started per year (2026 so far)
2010: 10 trials started20102011: 15 trials started2012: 10 trials started2013: 13 trials started2014: 23 trials started2015: 17 trials started20152016: 19 trials started2017: 18 trials started2018: 30 trials started2019: 22 trials started2020: 26 trials started20202021: 24 trials started2022: 33 trials started2023: 22 trials started2024: 37 trials started372025: 16 trials started2026: 16 trials started162026

Approved therapies

Approvals in the United States (FDA) and the European Union (EMA), one row per drug, regimen and tumour type. Open a row for the exact indication and source.

TherapyTumourUnited StatesEuropean Union
olaparib
FDA, 2018
metastatic HER2-negative, deleterious germline BRCA, after chemotherapy (neoadjuvant, adjuvant or metastatic); HR+ after endocrine therapy FDA regular approval 12/01/2018; current label 1.5. Source
FDA, 2022
adjuvant, high-risk early HER2-negative, deleterious germline BRCA FDA approval 11/03/2022; current label 1.4. Source
EU (EMA), 2019
locally advanced or metastatic HER2-negative, germline BRCA1/2 II/0020, EC decision 08/04/2019. HR-positive patients must also have progressed on endocrine therapy or be unsuitable for it. Source
EU (EMA), 2022
adjuvant, high-risk early HER2-negative, germline BRCA1/2 EC decision 02/08/2022. Monotherapy or with endocrine therapy. Source
Lynparza 		breast Approved 2018 Approved 2019
talazoparib
FDA, 2018
locally advanced or metastatic HER2-negative, deleterious germline BRCA Label 1.1. Year not checked against an FDA approval announcement (FDA's pre-2023 announcement archive was not reachable). Source
EU (EMA), 2019
locally advanced or metastatic HER2-negative, germline BRCA1/2 MA 20/06/2019. The EU prostate combination with enzalutamide is not biomarker-restricted. Source
Talzenna 		breast Approved 2018To verify Approved 2019
niraparib
FDA, 2017
maintenance, deleterious germline BRCA-mutated recurrent ovarian cancer in response to platinum Approved 2017 for all patients; on 11 Nov 2022, at FDA request, limited to deleterious germline BRCA (NOVA overall-survival data). Year = first approval in this setting. Source
Zejula 		ovarian Approved 2017 Not approved
olaparib
FDA, 2014
deleterious germline BRCA, after >=3 lines of chemotherapy AA 19/12/2014; converted to regular approval 17/08/2017 (FDA Verified clinical benefit list). No longer on the current label, so it is withdrawn; the withdrawal date (reported as 2022) was not checked against an FDA source. Source
FDA, 2017
maintenance, deleterious germline or somatic BRCA-mutated recurrent ovarian cancer in response to platinum Current label (rev. 7/2025, section 1.3) limits recurrent-ovarian maintenance to germline or somatic BRCA-mutated. Approved 2017 for all patients; year = first approval in this setting. Date the label was narrowed to BRCA not confirmed. Source
FDA, 2018
first-line maintenance, deleterious germline or somatic BRCA Label 1.1. Year not checked against an FDA approval announcement (FDA's pre-2023 announcement archive was not reachable). Source
EU (EMA), 2019
first-line maintenance, advanced BRCA1/2-mutated (germline and/or somatic) Lynparza first EU MA 16/12/2014. II/0023, EC decision 12/06/2019. Source
Lynparza 		ovarian Approved 2017To verify Approved 2019
olaparib with bevacizumab
FDA, 2020
first-line maintenance, advanced ovarian cancer in response to platinum, HRD-positive (deleterious BRCA mutation and/or genomic instability) Current label 1.2. Year (reported May 2020) not checked against an FDA announcement. Source
EU (EMA), 2020
first-line maintenance, advanced high-grade ovarian cancer in response after platinum + bevacizumab, HRD-positive (BRCA1/2 mutation and/or genomic instability) II/0035, EC decision 03/11/2020. HRD-positive includes BRCA1/2-mutated (broad). Source
LynparzaBroader label 		ovarian Approved 2020To verify Approved 2020
rucaparib
FDA, 2016
deleterious BRCA, after >=2 chemotherapies AA 19/12/2016; converted to regular approval 06/04/2018 (FDA Verified clinical benefit list). No longer on the current label (12/2022), so it is withdrawn; the exact withdrawal date was not checked against an FDA source. Source
FDA, 2018
maintenance, deleterious BRCA-mutated (germline and/or somatic) recurrent ovarian cancer in response to platinum Approved 2018 for all patients; later limited to BRCA-mutated (agent recorded 2022). Year = first approval in this setting. Label Recent Major Changes show Indications 1.1 changed 12/2022, restricting recurrent-disease maintenance (previously all patients) to BRCA-mutated. Date is from the label, not an FDA announcement. Source
EU (EMA), 2018
treatment of platinum-sensitive relapsed or progressive BRCA-mutated high-grade ovarian cancer after >=2 platinum lines, unable to tolerate further platinum Part of the initial conditional MA (23/05/2018). Removed after an Article 20 review of ARIEL4, which showed a detrimental effect on overall survival (CHMP opinion 21/07/2022, EC decision 21/09/2022). FDA equivalent: A127. Source
Rubraca 		ovarian Approved 2018 Withdrawn approved 2018
olaparib
FDA, 2019
maintenance after >=16 weeks of first-line platinum, deleterious germline BRCA FDA approval 27/12/2019; current label 1.6. Source
EU (EMA), 2020
maintenance after >=16 weeks of first-line platinum, germline BRCA1/2 II/0033, EC decision 03/07/2020. Source
Lynparza 		pancreatic Approved 2019 Approved 2020
niraparib with abiraterone acetate + prednisone
FDA, 2023
mCRPC, deleterious BRCA mutation FDA approval 11/08/2023. Source
FDA, 2025
mCSPC, deleterious or suspected deleterious BRCA2 mutation FDA approval 12/12/2025. Restricted to BRCA2 (BRCA1 not included). Source
EU (EMA), 2023
mCRPC, BRCA1/2 mutation (germline and/or somatic), chemotherapy not indicated MA 19/04/2023. mHSPC BRCA1/2 indication added 2026 (own row). Source
EU (EMA), 2026
mHSPC with BRCA1/2 mutations (germline and/or somatic), with hormone therapy CHMP opinion 29/01/2026, EC decision 05/03/2026. Source
Akeega 		prostate Approved 2023 Approved 2023
olaparib
FDA, 2020
mCRPC with deleterious germline or somatic HRR gene mutation, after enzalutamide or abiraterone Label 1.7: HRR gene-mutated (includes BRCA1/2). Year not checked against an FDA approval announcement (FDA's pre-2023 announcement archive was not reachable). Source
EU (EMA), 2020
mCRPC, BRCA1/2 (germline and/or somatic), after a new hormonal agent II/0036, EC decision 03/11/2020. Source
Lynparza 		prostate Approved 2020To verify Approved 2020
olaparib with abiraterone + prednisone
FDA, 2023
mCRPC, deleterious BRCA mutation FDA approval 31/05/2023; current label 1.8. The EU combination is not BRCA-restricted. Source
Lynparza 		prostate Approved 2023 Not approved
rucaparib
FDA, 2020
mCRPC, deleterious BRCA mutation (germline and/or somatic), previously treated with androgen receptor-directed therapy AA 15/05/2020 (after AR-directed therapy and a taxane); converted to regular approval 17/12/2025 based on TRITON3, and the taxane requirement was dropped. DailyMed label (12/2022) not yet updated. Source
Rubraca 		prostate Approved 2020 Not approved
talazoparib with enzalutamide
FDA, 2023
mCRPC with HRR gene mutation Label 1.2: HRR gene-mutated mCRPC. The EU combination is not biomarker-restricted. Year not checked against an FDA approval announcement (FDA's pre-2023 announcement archive was not reachable). Source
TalzennaBroader label 		prostate Approved 2023To verify Not approved

Companies

Industry sponsors leading active trials, by number of trials. Each square is one trial, shaded by phase.

  1. AstraZeneca 10
  2. GSK 4
  3. Genmab 3
  4. Innovent Biologics 2
  5. Kelun-Biotech 2
  6. AbbVie 2
  7. Gilead Sciences 2
  8. Impact Therapeutics 1
  9. AGO Research 1
  10. Danatlas Pharmaceuticals 1
  11. MSD (Merck & Co.) 1
  12. Alyssum Therapeutics 1
  13. Artios Pharma 1
  14. Ever Supreme Bio Technology 1
  15. Immunitas Therapeutics 1

Trials

Matched automatically from registry text, so a few trials may only mention BRCA1/2 mutation rather than require it. Check the quoted criterion, and the registry entry before relying on a match.

168 of 441 trials shown

  1. Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations

    Active, not recruiting Phase 4 AstraZeneca Started 2022 NCT05457257

    olaparib FDA EUenzalutamideabiraterone acetatePrednisone

    Deleterious or suspected deleterious BRCA1/2 mutation in tumor tissue.

    Metastatic Castration-resistant Prostate Cancer

  2. Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations

    Recruiting Phase 3 SWOG Cancer Research Network Started 2026 NCT06998940

    FluorouracilGemcitabineIrinotecanIrinotecan SucrosofateLeucovorinNab-paclitaxel

    Prior maintenance therapy with Olaparib or Rucaparib for germline or somatic BRCA1/2 or PALB2 mutations does not count as a line of therapy.

    Locally Advanced Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8

  3. A Study to Investigate Mocertatug Rezetecan With Bevacizumab Compared With Platinum Doublet With Bevacizumab in Participants With Platinum-sensitive Ovarian Cancer (BEHOLD-Ovarian02)

    Recruiting Phase 3 GSK Started 2026 NCT07684612

    Mocertatug rezetecan (Mo-Rez)CarboplatinPaclitaxelGemcitabinePegylated liposomal doxorubicin (PLD)Bevacizumab

    …al testing (compliant to local regulations) for tumor and/or germline Breast Cancer Gene (BRCA1 and BRCA2) mutation.

    Ovarian Neoplasms

  4. Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer

    Recruiting Phase 3 Genmab Started 2026 NCT07564141

    Rina-SBevacizumabCarboplatinGemcitabinePaclitaxelPLD

    …cizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease.

    Platinum-Sensitive Ovarian Cancer, Ovarian Cancer

  5. Carboplatin-Enhanced Therapy in BRCA-Mutated or Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer

    Not yet recruiting Phase 3 Gustave Roussy, Cancer Campus, Grand Paris Started 2026 NCT07591467

    Experimental

    Presence of pathogenic BRCA gene alteration (BRCAm cohort) OR histologically adenocarcinoma of the prostate with neuroendocrine diffe…

    BRCA-Mutated, Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer, Prostate Cancer

  6. A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01)

    Recruiting Phase 3 GSK Started 2026 NCT07286266

    Mocertatug rezetecanPaclitaxelPegylated liposomal doxorubicin (PLD)TopotecanGemcitabinePembrolizumab

    PARPi, in participants with known or suspected deleterious germline or somatic BRCA mutations and who achieved a complete or partial response to platinum-based chemotherapy must have …

    Ovarian Neoplasms

  7. Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy

    Recruiting Phase 3 Genmab Started 2026 NCT07225270

    Rina-SBevacizumab

    Participants with known breast cancer (BRCA)-mutated (somatic or germline) or homologous recombination deficiency (HRD)-positive ovarian cance…

    Ovarian Cancer, Platinum-sensitive Ovarian Cancer, PSOC

  8. Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

    Active, not recruiting Phase 3 Innovent Biologics Started 2025 NCT06834672

    IBI354paclitaxel/Gemcitabine/Liposomal doxorubicin

    …d prior treatment with a PARP inhibitor.This study allowed the inclusion of subjects with BRCA mutations identified during the platinum-resistant phase who were PARP inhibitor-naïve.

    Ovarian, Primary Peritoneal, Fallopian Tube Cancer

  9. Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer

    Recruiting Phase 3 NRG Oncology Started 2025 NCT06580314

    BevacizumabOlaparib FDA EU

    Other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic), (excluding tumors that are known mismatch repair defici…

    Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, Fallopian Tube Malignant Mixed Mesodermal (Mullerian) Tumor, FIGO Stage III Ovarian Cancer 2014

  10. A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation

    Recruiting Phase 3 AstraZeneca Started 2025 NCT06952803

    SaruparibAbiraterone + Prednisolone/PrednisoneAndrogen Deprivation Therapy (ADT)

    …uparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation

    Prostate Cancer

  11. Fluorizoparib Plus Apatinib Versus Chemotherapy in HRD-positive, HER2-negative Advanced Breast Cancer

    Active, not recruiting Phase 3 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Started 2024 NCT07371910

    Chemotherapy/ADC RegimenFluorizoparibApatinibPhysician's Choice Chemotherapy/ADC Regimen

    Documented HRD-positive status (defined as BRCA1/2 mutation and/or HRD positive).

    Metastatic Breast Cancer, HRD-Positive/HER2-Negative Advanced Breast Cancer

  12. PARPi or Capecitabine Combined With PD-1 Inhibitors as Adjuvant Therapy in High-risk TNBC

    Recruiting Phase 3 Guangdong Provincial People's Hospital Started 2024 NCT06533384

    As per the germline BRCA1/2 mutation status, the selection of either Fuzuloparib or capecitabine in combination with Camrelizumab is made for adjuvant therapy.9 cycles of Camrelizumab as adjuvant therapy.

    PARPi or Capecitabine Combined With PD-1 Inhibitors Was Selected Based on the Germline BRCA1/2 Mutation vs. PD-1 Inhibitors Alone as Adjuvant Therapy in High-risk Non-pCR TNBC

    Triple-negative Breast Cancer

  13. Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer

    Recruiting Phase 3 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Started 2024 NCT06255392

    FluzoparibApatinib MesylateCapecitabine tabletsVinorelbine Tartrate OralEribulin mesylate injectionGemcitabine Hydrochloride

    3) The patient's HRD test was positive (definition: BRCA1/2 mutation, or HRD score greater than or equal to 42 points)

    Fludzoparib" and Anti-angiogenic, HRD-positive/HER2-negative Advanced Breast Cancer

  14. Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

    Recruiting Phase 3 AstraZeneca Started 2024 NCT06380751

    Saruparib (AZD5305)CamizestrantAbemaciclibRibociclibPalbociclibFulvestrant

    Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2

    Advanced Breast Cancer

  15. Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation

    Active, not recruiting Phase 3 Alliance for Clinical Trials in Oncology Started 2023 NCT04711109

    Denosumab

    Women with a confirmed deleterious or likely deleterious BRCA 1 germline mutation (variant class 4 or 5)

    BRCA1 Mutation, Breast Cancer, Breast Diseases, Breast Neoplasms

  16. SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

    Active, not recruiting Phase 3 Kelun-Biotech Started 2022 NCT05347134

    SKB264

    For patients with documented germline BRCA1/BRCA2 mutations, if they have been treated with an approved PARP inhibitor, then the PARP inhibitor can b…

    Triple Negative Breast Cancer

  17. PSMA PET Additive Value for Prostate Cancer Diagnosis in Men With Negative/Equivocal MRI

    Active, not recruiting Phase 3 Peter MacCallum Cancer Centre, Australia Started 2022 NCT05154162

    BRCA mutation

    Prostate Cancer

  18. Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

    Active, not recruiting Phase 3 GSK Started 2021 NCT04915755

    Niraparib FDA EU

    …the Efficacy and Safety of Niraparib to Placebo in Participants With Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer With Molecular Disease Based on Presence of Circulating …

    Neoplasms, Breast

  19. A Study of IMP4297 as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer

    Active, not recruiting Phase 3 Impact Therapeutics Started 2019 NCT04169997

    IMP4927Placebos

    … histologically confirmed FIGO stage III-IV high grade serous, high grade endometrioid or BRCA mutant other histological types of epithelial ovarian cancer, fallopian tube cancer or primary p…

    Ovarian Cancer

  20. Platinum and Polyadenosine 5'Diphosphoribose Polymerisation Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer and/or Germline BRCA Positive Breast Cancer

    Recruiting Phase 2/3 Cambridge University Hospitals NHS Foundation Trust Started 2016 NCT03150576

    Olaparib FDA EUPaclitaxel and Carboplatin

    Germline BRCA (gBRCA) mutation positive, HER2 negative, and PgR / ER of any status.

    Status may be outdated, last updated 2022-11-14Breast Cancer

  21. Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer

    Active, not recruiting Phase 3 Alliance for Clinical Trials in Oncology Started 2015 NCT01905046

    metformin hydrochloride

    Known breast cancer (BRCA)1 or BRCA2 mutation carrier providing that the woman has

    Breast Atypical Ductal Hyperplasia, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ

  22. High Dose Chemotherapy in Oligo-metastatic Homologous Recombination Deficient Breast Cancer

    Active, not recruiting Phase 3 The Netherlands Cancer Institute Started 2014 NCT01646034

    carboplatin, thiotepa, and cyclophosphamidechemotherapy (docetaxel, doxorubicin, cyclofosfamide, carboplatin, paclitaxel, gemcitabine)

    …or is deficient in homologous recombination and/or the patient has a deleterious germline BRCA1 or BRCA2 mutation.

    Status may be outdated, last updated 2022-10-12Breast Cancer

  23. Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

    Active, not recruiting Phase 3 AstraZeneca Started 2014 NCT02032823

    Olaparib FDA EU

    Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicte…

    Breast Cancer

  24. Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

    Active, not recruiting Phase 3 AstraZeneca Started 2013 NCT01874353

    Olaparib 300mg tablets FDA EU

    Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicte…

    Platinum Sensitive, BRCA Mutated, Relapsed Ovarian Cancer, Following Complete or Partial Response to Platinum Based Chemotherapy

  25. Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

    Active, not recruiting Phase 3 AstraZeneca Started 2013 NCT01844986

    Olaparib 300mg tablets FDA EU

    … with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer an…

    Newly Diagnosed, Advanced Ovarian Cancer, FIGO Stage III-IV, BRCA Mutation

  26. Vilastobart+Retifanlimab in BRCA or PALB2 Deficient PC

    Not yet recruiting Phase 2 Massachusetts General Hospital Starts 2027 NCT07765836

    vilastobart (XTX101)Retifanlimab

    Participant must have a germline or somatic pathogenic alteration in BRCA1, BRCA2, or PALB2 on tumor next generation sequencing (NGS) performed using a CLIA certif…

    Pancreatic Cancer Metastatic

  27. Lorigerlimab (MGD019) in Patients With Pancreatic Adenocarcinoma and Homologous Recombination Deficiency

    Not yet recruiting Phase 2 University of Miami Starts 2027 NCT07565155

    Lorigerlimab

    Documented germline mutation in BRCA1, BRCA2, PALB2, radiation sensitive protein 51 C (RAD51C), or radiation sensitive protein…

    Pancreatic Adenocarcinoma, Homologous Recombination Deficiency

  28. A Study of DAT-2645 in Patients With BRCA1/2 Mutations or HRD-Positive Ovarian Cancer

    Not yet recruiting Phase 2 Danatlas Pharmaceuticals Started 2026 NCT07652073

    DAT-2645 tablet

    A Study of DAT-2645 in Patients With BRCA1/2 Mutations or HRD-Positive Ovarian Cancer

    Advanced or Metastatic Ovarian Cancer

  29. A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors

    Recruiting Phase 2 Kelun-Biotech Started 2026 NCT07448922

    SKB518 for injectionCarboplatin (AUC 5)BevacizumabSKB518 for injection

    Participants in Cohorts A, C, D, and E with known breast cancer susceptibility gene (BRCA) mutations must have received poly(ADP-ribose) polymerase (PARP) inhibitor therapy, unless contraind…

    Advanced Gynecological Malignancies

  30. [18F]Fluorthanatrace - Positron Emission Tomography (FTT-PET) and ctDNA to Predict Response to PARP Inhibitor Therapy in Metastatic Prostate Cancer (mPC)

    Not yet recruiting Phase 2 Washington University School of Medicine Started 2026 NCT07723651

    1-(4-(2-Fluoroethoxy)phenyl)-8,9-dihiydro-2,7,9a-triazabenzo[cd]azulen-6(7H)-one

    … CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C for Talazoparib/enzalutamide and ATMm, BRCA1m, BRCA2m, BARD1m, BRIP1m, CDK12m, CHEK1m, CHEK2m, FANCLm, PALB2m, RAD51Bm, RAD51Cm, RAD51D…

    Metastatic Prostate Cancer, Prostate Cancer

  31. Saruparib in HRDsig+ Solid Tumors

    Not yet recruiting Phase 2 Abramson Cancer Center at Penn Medicine Started 2026 NCT07832630

    Saruparib

    Patients in Cohort A must also have a documented pathogenic germline or somatic variant in BRCA1, BRCA2, PALB2, RAD51B, RAD51C, RAD51D or BARD1 as assessed by a CLIA certified laborator…

    Malignant Neoplastic Disease (Disorder)

  32. Study of TUB-040 Given With Standard Ovarian Cancer Drugs in Patients With Fast-growing Ovarian Cancer

    Recruiting Phase 1/2 Gilead Sciences Started 2026 NCT07736937

    TUB-040 + Carbo + BEV

    … patients who were previously documented to be HRD positive or have a germline or somatic BRCA 1/2 mutation), if PARPi therapy was locally approved at the time of testing.

    Ovarian Cancer

  33. An Open-label, First-in-Human, Dose-Escalation and Dose-Expansion Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPR1020 in Patients With Advanced Solid Tumors

    Recruiting Phase 1/2 Shanghai SciBrunch Therapeutics Started 2026 NCT07359066

    SRP1020

    …n-resistant prostate cancer (CRPC), who have a documented pathogenic or likely pathogenic BRCA mutation (BRCAm, germline or somatic) as detected by a local or central laboratory, and who have e…

    Advanced Solid Tumors, PARP Inhibitor

  34. Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy

    Recruiting Phase 2 National Cancer Institute (NCI) Started 2026 NCT07504588

    Anti-VEGF Monoclonal AntibodyBevacizumabCarboplatinGemcitabinePegylated Liposomal Doxorubicin HydrochlorideSacituzumab Govitecan

    Disease must be germline or somatic BRCA1 or BRCA2 mutated or homologous recombination deficiency test positive

    Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma, Recurrent Platinum-Sensitive Ovarian High Grade Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Ovarian High Grade Serous Adenocarcinoma

  35. Personalized Timing of Interval Debulking Surgery in Advanced Ovarian Cancer

    Recruiting Phase 2 The University of Hong Kong Started 2025 NCT07023484

    Carboplatin plus Paclitaxel

    Patients must have either germline and / or somatic BRCA test, or homologous recombination deficiency (HRD) test.

    Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

  36. A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer

    Active, not recruiting Phase 1/2 Pfizer Started 2025 NCT06966453

    Disitamab vedotin

    Participants with known germline breast cancer gene (BRCA) mutation must have received a poly-ADP ribose polymerase (PARP) inhibitor, where available and not…

    Breast Cancer, Breast Neoplasms

  37. Sacituzumab Tirumotecan Plus Anlotinib for Metastatic Triple Negative Breast Cancer

    Not yet recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital Started 2025 NCT07139470

    Sacituzumab Tirumotecan + anlotinib

    For patients with documented germline BRCA1/BRCA2 mutations, if they have been treated with an approved PARP inhibitor, then the PARP inhibitor can b…

    Triple Negative Breast Cancer

  38. Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial

    Recruiting Phase 2 Alliance for Clinical Trials in Oncology Started 2025 NCT06632977

    Valemetostat TosylateCarboplatinCabazitaxelAbiraterone AcetateEnzalutamideLutetium Lu 177 Vipivotide Tetraxetan

    Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi.

    Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8

  39. A Study of IBI363 Combination Therapy in Participants With Advanced Solid Tumors

    Not yet recruiting Phase 2 Innovent Biologics Started 2025 NCT07124793

    IBI363+IBI305

    Subjects with a documented breast cancer gene (BRCA) mutation (germline and/or somatic) must have been previously treated with a poly(ADP-ribose) polym…

    EGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer

  40. Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib ± Camrelizumab

    Recruiting Phase 2 Fudan University Started 2024 NCT06516289

    HRS-1167FamitinibCamrelizumab

    Patients with pathogenic germline BRCA 1/2 mutation.

    BRCA-Mutated Breast Carcinoma, HER2-negative Breast Cancer

  41. A Safety And Efficacy Study Of Allogeneic CAR Gamma-Delta T Cells in Subjects With Relapsed/Refractory Solid Tumors

    Recruiting Phase 1/2 Ever Supreme Bio Technology Started 2024 NCT06150885

    HLA-G-CAR.BiTE allogeneic γδ T cells

    … as antibody drug conjugate (such as Sacituzumab govitecan-hzi), PARP inhibitor, germline BRCA1/BRCA2 mutation (such as Olaparib and Talazoparib), HER2-targeted therapy for HER2-positive disease and e…

    Solid Tumor

  42. Arsenous Acid for Refractory Triple-Negative Breast Cancer

    Recruiting Phase 2 Sun Yat-sen University Started 2024 NCT06678048

    Arsenous Acid plus Chemotherapy

    Additionally, TNBC patients with a known germline breast cancer susceptibility gene (BRCA) mutation, who are assessed to be unsuitable for or unable to receive poly (ADP-ribose) polymerase …

    Breast Cancer

  43. I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers

    Not yet recruiting Phase 1/2 Institut Paoli-Calmettes Started 2024 NCT05986071

    M1774Fulvestrant injection

    Germline or somatic BRCA1, BRCA2 or PALB2 mutations and prior exposure and resistance to PARP inhibitors (cohort 1…

    Status may be outdated, last updated 2024-03-29Breast Cancer

  44. Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer

    Recruiting Phase 2 Okayama University Started 2024 NCT05485766

    PembrolizumabPaclitaxelCarboplatinOlaparib FDA EU

    Confirmed germline BRCA 1/2 mutated.

    Triple Negative Breast Neoplasms, Triple Negative Breast Cancer, Breast Neoplasms, Breast Cancer

  45. A Study of Second Look Laparoscopy (SLL) in People With Ovarian Cancer Who Have Completed Their First Course of Chemotherapy

    Active, not recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2024 NCT06240598

    Confirmation of deleterious Somatic or Germline BRCA mutation

    Ovarian Cancer

  46. Decitabine/Cedazuridine (INQOVI), an Oral DNA Demethylating Agent, in Subjects With BAP1 Cancer Predisposition Syndrome and Subclinical, Early-Stage Mesothelioma

    Recruiting Phase 2 National Cancer Institute (NCI) Started 2024 NCT05960773

    Decitabine/cedazuridine

    Participants with history of germline BRCA1-Associated Protein-1 (BAP1) mutations.

    Mesothelioma, Malignant Mesothelioma (MM), Early-stage Mesothelioma, Subclinical Mesothelioma

  47. Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation

    Recruiting Phase 2 SWOG Cancer Research Network Started 2024 NCT05806515

    Carboplatin

    …in Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation

    Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8

  48. Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors

    Recruiting Phase 1/2 Alyssum Therapeutics Started 2024 NCT06234098

    AT-1965 Liposome Injection

    …ith either Low HER2 (IHC 1+ or IHC 2+/in situ hybridization-negative), PD-L1 (CPS\>10) or BRCA mutation need to have prior FDA approved available therapies before participation in this expansio…

    Solid Tumor

  49. A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression

    Active, not recruiting Phase 2 AbbVie Started 2024 NCT06365853

    Mirvetuximab SoravtansineLubricating Eye DropsPrednisolone acetate ophthalmic suspension 1% eye dropsBrimonidine tartrate ophthalmic solution eye drops

    Participants with known breast cancer susceptibility gene (BRCA) mutations (tumor or germline) must have received poly (ADP-ribose) polymerase inhibitors (PARPi).

    Recurrent Ovarian Cancer, Folate Receptor-Alpha Positive

  50. Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer

    Recruiting Phase 2 GBG Forschungs Started 2024 NCT06201234

    Olaparib + Elacestrant FDA EUOlaparib FDA EU

    …e Receptor (HR)-Positive, HER2-negative Locally Advanced or Metastatic Breast Cancer With gBRCA1/2 Mutations

    Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer, BRCA1 Mutation, BRCA2 Mutation

  51. Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer

    Recruiting Phase 2 Qilu Hospital of Shandong University Started 2024 NCT06735326

    FluzoparibBevacizumabPaclitaxelCarboplatin

    Confirmed germline BRCA1/2 mutations by professional genetic testing.

    Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

  52. Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression

    Recruiting Phase 2 MedSIR Started 2024 NCT06180356

    Niraparib oral tablets FDA EU

    Note I: Patients with germline or somatic mutations in the BRCA1 or BRCA2 genes will be considered with the HR status known and classified as with homolo…

    Ovarian Cancer, Oligometastatic Disease, Serous Ovarian Tumor

  53. Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells Delivered Intraperitoneally for the Management of Platinum Resistant Ovarian Cancer, Mesonephric-like Adenocarcinoma, and Pancreatic Cancer

    Active, not recruiting Phase 1/2 M.D. Anderson Cancer Center Started 2023 NCT05922930

    TROP2-CAR-NKCyclophosphamideFludarabine

    To be eligible, germline/somatic BRCA1/2 mutation carriers should have received prior PARPi therapy.

    Pancreatic Cancer, Ovarian Cancer, Adenocarcinoma

  54. Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)

    Recruiting Phase 1/2 Artios Pharma Started 2023 NCT05898399

    ART6043Olaparib FDA EU

    Documentation of a deleterious or suspected deleterious gBRCA mutation.

    Advanced Solid Tumor, Metastatic Solid Tumor

  55. Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2023 NCT05700721

    Niraparib FDA EUDostarlimab

    Advanced BRCA1/2m cancer 2.

    Brain Metastases

  56. Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)

    Recruiting Phase 2 German Cancer Research Center Started 2023 NCT05332561

    Atezolizumab 1200 mg in 20 ML InjectionInavolisibIpatasertibOlaparib FDA EUSacituzumab govitecanTrastuzumab/pertuzumab

    Arm 4 (Olaparib, PARP, DNA-Repair): Inactivating somatic or germline BRCA1/2 mutation including homozygous deletions, Inactivating germline PALB2 mutations

    Early-stage Breast Cancer

  57. Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations

    Active, not recruiting Phase 2 Rana McKay, MD Started 2023 NCT05498272

    Olaparib FDA EULHRH agonist

    Must have evidence of germline or somatic BRCA1/2, PALB2, RAD51B, RAD51C, RAD51D, RAD54L2, BARD1, FANCA, BRIP1, CHEK2, ATM, and CDK12 ge…

    Prostate Cancer, BRCA1 Mutation, BRCA2 Mutation, Prostatic Adenocarcinoma

  58. First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer

    Not yet recruiting Phase 2 Sun Yat-sen University Started 2023 NCT06063070

    Fluzoparib CapsulesBevacizumab

    Germline BRCA1/2 wild-type.

    Status may be outdated, last updated 2023-10-02Ovarian Cancer, High Grade Serous Adenocarcinoma of Ovary, High Grade Endometrioid Ovarian Cancer, Primary Peritoneal Cancer

  59. Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI

    Recruiting Phase 1/2 Maastricht University Medical Center Started 2023 NCT04954599

    CP-506CarboplatinImmune checkpoint inhibitor

    BRCA1/2 carriers), dedicated HRD genomic assays (including exome-sequencing) from liquid or tissue biopsie…

    Unspecified Adult Solid Tumor, Protocol Specific

  60. Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab

    Recruiting Phase 2 Peking University Cancer Hospital & Institute Started 2023 NCT06141265

    Niraparib FDA EU

    Genetic testing of tumor tissue indicates HRD positive or germline/somatic BRCA mutation prior to enrollment.

    Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

  61. Niraparib in Tumors Metastatic to the CNS

    Active, not recruiting Phase 2 Massachusetts General Hospital Started 2022 NCT04992013

    Niraparib FDA EU

    …le negative breast cancer or ovarian cancer, or any cancer histology with the presence of alteration in BRCA1, BRCA2, PARP metabolism, DNA repair pathways and HRD (homologous recombination deficienc…

    Metastatic Cancer, Central Nervous System Cancer

  62. Evaluating the Efficacy and Safety of Fulvestrant Plus DNA Damage Repair Inhibitors After a CDK4/6 Inhibitor

    Recruiting Phase 2 Seoul National University Hospital Started 2022 NCT05536128

    Olaparib FDA EUFulvestrant

    13. \<For cohort A\> Patients with known germline or somatic mutations of BRCA1 or BRCA2

    Advanced Breast Cancer

  63. Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas

    Active, not recruiting Phase 1/2 Immunitas Therapeutics Started 2022 NCT05565417

    IMT-009Fruquintinib

    a PARPi for patients with gBRCA mutations

    Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer, Cutaneous Squamous Cell Carcinoma

  64. WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC

    Recruiting Phase 2 AGO Research Started 2022 NCT04644289

    olaparib FDA EUdurvalumab

    … epithelial ovarian, fallopian tube or primary peritoneal cancer or known (BReast CAncer) BRCA mutation and any histologic type

    Epithelial Ovarian Cancer

  65. Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer

    Recruiting Phase 2 ARCAGY/ GINECO GROUP Started 2022 NCT05183984

    ChemotherapyBevacizumab-AwwbNiraparib FDA EU

    …ther epithelial non mucinous and non-clear cell ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation, c.

    Ovarian Cancer

  66. Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation

    Recruiting Phase 2 Ying Lin Started 2022 NCT05761470

    CamrelizumabFluzoparibNab-paclitaxel

    HRR gene mutation: at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D g…

    Status may be outdated, last updated 2023-03-09Her-2 Negative Breast Cancer, HRR Gene Mutation

  67. Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer

    Active, not recruiting Phase 2 AbbVie Started 2022 NCT05456685

    Mirvetuximab soravtansineCarboplatin

    Somatic and germline BRCA-positive participants must have received prior treatment with a poly adenosine phosphate-ribose po…

    High Grade Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

  68. Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases

    Active, not recruiting Phase 1/2 Colette Shen Started 2022 NCT04711824

    Olaparib FDA EUDurvalumabPhysicians Choice systemic chemotherapy FDA EU

    or 2) HER2-negative (with ER/PR expression \>=10% with germline or somatic BRCA mutation.

    Breast Cancer, Brain Metastases, Adult

  69. Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

    Recruiting Phase 1/2 Genmab Started 2022 NCT05579366

    Rina-SCarboplatinBevacizumabPembrolizumabErythromycinItraconazole

    Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration \[FDA\]-approved test in a Clinical Labora…

    High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer

  70. A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer

    Active, not recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2022 NCT05203445

    Olaparib FDA EUPembrolizumab

    All patients must have a germline mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.

    Breast Cancer

  71. Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study

    Recruiting Phase 2 Peking University People's Hospital Started 2022 NCT05576389

    Camrelizumab+Fluzoparib

    Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study

    Germline BRCA-mutated HER2-negative Breast Cancer

  72. Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2022 NCT05327010

    BET Bromodomain Inhibitor ZEN-3694Talazoparib FDA EU

    Patients in Cohort 1 must have (i) a germline or somatic mutation in BRCA1 or BRCA2

    Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm

  73. Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

    Recruiting Phase 1/2 AstraZeneca Started 2022 NCT05417594

    AZD9574Temozolomide (TMZ)[11C]AZ1419 3391Trastuzumab Deruxtecan (T-DXd)Datopotamab Deruxtecan (Dato-DXd)

    …ced or metastatic disease and evidence of a predicted loss of function germline or tumour mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D,

    Advanced Solid Malignancies

  74. Niraparib + Dostarlimab In BRCA Mutated Breast Cancer

    Active, not recruiting Phase 2 Dana-Farber Cancer Institute Started 2021 NCT04584255

    Niraparib FDA EUDostarlimab

    Participants must have documented germline mutation in BRCA1, BRCA2 or PALB2 that is deleterious or suspected to be deleterious (known or predicted t…

    Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Breast Cancer

  75. APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation

    Recruiting Phase 2 National Cancer Institute (NCI) Started 2021 NCT04858334

    Olaparib FDA EU

    Patient must have a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2, or PALB2, as determined by a Clinical Laboratory Improvement Amendments (CLIA) c…

    Pancreatic Acinar Cell Carcinoma, Pancreatic Adenosquamous Carcinoma, Pancreatic Squamous Cell Carcinoma, Resectable Pancreatic Acinar Cell Carcinoma

  76. Talazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency

    Recruiting Phase 2 Seoul National University Hospital Started 2021 NCT04892693

    Talazoparib Oral Capsule FDA EU

    Germline or Somatic BRCA1/2 mutation

    Advanced Breast Cancer

  77. Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial

    Recruiting Phase 2 Massachusetts General Hospital Started 2021 NCT03990896

    Talazoparib FDA EU

    Metastatic breast cancer with deleterious somatic BRCA 1 or 2 mutations detectable by cell-free circulating tumor DNA, by CLIA certified clinical assay (includin…

    Breast Cancer

  78. Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer

    Active, not recruiting Phase 2 Tongji Hospital Started 2021 NCT04507841

    Niraparib FDA EU

    BRCA1/2 gene mutation or HRD was confirmed by tissue or blood samples detected by the testing institution desig…

    Ovarian Cancer

  79. PALbociclib Endocrine Therapy Followed by Talazo Vs. Talazoz-Atezo Study

    Recruiting Phase 2 Samsung Medical Center Started 2021 NCT04819243

    Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, Atezolizumab FDA EUPabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, FDA EU

    Confirmed germline pathogenic BRCA1 and/or BRCA2 mutation or 35 HRD-related gene alterations (see Appendix 16.5)

    Premenopausal HR+/HER2- Metastatic Breast Cancer

  80. Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2021 NCT04550494

    Talazoparib FDA EU

    Deleterious BRCA1 or BRCA2 mutations

    Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Clinical Stage III Gastric Cancer AJCC v8

  81. Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2021 NCT04548752

    Olaparib FDA EUPembrolizumab

    Patients must have one of the following mutations: germline mutation in BRCA 1 or 2 that was tested in a Clinical Laboratory Improvement Act (CLIA) certified lab defi…

    Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8

  82. Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma

    Recruiting Phase 2 Shandong University Started 2021 NCT04716686

    Niraparib FDA EU

    …f endometrial cancer have received \>2 lines of platinum containing chemotherapy and have BRCA mutation or be defined as HRD positive

    Status may be outdated, last updated 2024-01-05Endometrial Carcinoma, Serous Carcinoma

  83. Study of Sacituzumab Govitecan in Chinese Patients With Metastatic Triple-negative Breast Cancer Who Received at Least Two Prior Treatments

    Active, not recruiting Phase 2 Gilead Sciences Started 2020 NCT04454437

    Sacituzumab Govitecan-hziy

    For individuals with a documented germ-line BRCA1/BRCA2 mutation who received an approved PARP inhibitor, the PARP inhibitor can be used to meet the crite…

    Metastatic Triple-negative Breast Cancer

  84. Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer

    Recruiting Phase 2 M.D. Anderson Cancer Center Started 2020 NCT04090567

    CediranibCeralasertibOlaparib FDA EU

    Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer

    Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8

  85. PLATFORM Study of Precision Medicine for Rare Tumors

    Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2020 NCT04423185

    Almonertinib 110 MGDacomitinib 45 MGAlectinib 150 MGCrizotinib 250 MGPyrotinib 160/80 MGImatinib 400 MG

    …R mutation, ALK fusion, ROS-1 fusion, C-MET amplification, C-MET mutation, BRAF mutation, BRCA1/2 mutation, C-KIT mutation, HER-2 mutation HER-2 over expression/amplification, CDKN2A mutation pati…

    Rare Tumor

  86. Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients.

    Active, not recruiting Phase 2 UNICANCER Started 2019 NCT04053322

    DurvalumabOlaparib FDA EUFulvestrant

    Documented personal germline alteration in BRCA1 or BRCA2 that is predicted to be deleterious.

    ER-positive and HER2-negative Metastatic or Locally Advanced Breast Cancer, a Germline or Somatic BRCA Mutation, or a Deleterious Alteration of Other Genes Involved in Homologous Recombination Repair (HRR) or in MSI Status

  87. Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers

    Active, not recruiting Phase 1/2 Kari Wisinski Started 2019 NCT03911973

    GedatolisibTalazoparib FDA EU

    Phase II Cohort B \[CLOSED\]: Patients with advanced HER2 negative breast cancer and a germline BRCA1 or 2 (1/2) mutation

    Status may be outdated, last updated 2024-06-07TNBC - Triple-Negative Breast Cancer

  88. Carboplatin or Olaparib for BRcA Deficient Prostate Cancer

    Recruiting Phase 2 VA Office of Research and Development Started 2019 NCT04038502

    CarboplatinOlaparib FDA EU

    Carboplatin or Olaparib for BRcA Deficient Prostate Cancer

    Metastatic Castrate Resistant Prostate Cancer, BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D, or RAD54L Mutations

  89. FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test

    Recruiting Phase 2 Erasmus Medical Center Started 2019 NCT06193525

    Talazoparib FDA EU

    the patient must have a proven germline or somatic BRCA1 and/or BRCA2 mutation The Bloom \& Richardson grading is always based on the primary tumor.

    Advanced Breast Cancer

  90. Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002)

    Active, not recruiting Phase 2 MSD (Merck & Co.) Started 2018 NCT03742895

    Olaparib FDA EU

    …ts who have non-breast or ovarian cancers that are breast cancer susceptibility gene 1/2 (BRCA1/2) mutated (BRCAm), or who have cancers that are homologous recombination repair mutated (HRRm) but …

    Advanced Solid Neoplasms

  91. ASA in Prevention of Ovarian Cancer (STICs and STONEs)

    Active, not recruiting Phase 2 Canadian Cancer Trials Group Started 2018 NCT03480776

    Acetylsalicylic acid

    Previously documented germline BRCA1/2 pathogenic mutation or likely pathogenic variant based on the ACMG 2015 guidelines

    Ovarian Cancer Prevention

  92. Adavosertib With or Without Olaparib in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2018 NCT03579316

    AdavosertibOlaparib FDA EUCeralasertib

    Are germline or somatic BRCA mutant or HRD positive by a licensed test prior to enrollment.

    Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma

  93. Olaparib In Metastatic Breast Cancer

    Active, not recruiting Phase 2 Beth Israel Deaconess Medical Center Started 2018 NCT03344965

    Olaparib FDA EU

    Cohort 2a: somatic mutation of BRCA 1 or BRCA 2

    Metastatic Breast Cancer, Invasive Breast Cancer, Somatic Mutation Breast Cancer (BRCA1), Somatic Mutation Breast Cancer (BRCA2)

  94. Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2017 NCT02849496

    AtezolizumabOlaparib FDA EU

    …d unresectable locally advanced or metastatic non-HER2-positive breast cancer and a known BRCA 1/2 mutation present

    Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable Breast Carcinoma, Metastatic Breast Carcinoma

  95. Testing AZD1775 as a Potential Targeted Treatment in Cancers With BRCA Genetic Changes (MATCH-Subprotocol Z1I)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2017 NCT04439227

    Adavosertib

    Patients must have mutation in the BRCA1 or BRCA2 gene in the tumor, or another aberration, as determined via the MATCH Master Pr…

    Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma

  96. PARP-inhibition and CTLA-4 Blockade in BRCA-deficient Ovarian Cancer

    Active, not recruiting Phase 1/2 New Mexico Cancer Research Alliance Started 2016 NCT02571725

    Olaparib FDA EUTremelimumab

    Patients must have a confirmed germline mutation in the BRCA1 or BRCA2 gene

    Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

  97. A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.

    Active, not recruiting Phase 1/2 AstraZeneca Started 2016 NCT02734004

    Olaparib FDA EUMEDI4736Bevacizumab

    gBRCAm HER2-negative metastatic breast cancer (module 2)

    Ovarian, Breast, SCLC, Gastric Cancers

  98. Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)

    Active, not recruiting Phase 1/2 Priyanka Sharma Started 2015 NCT02393794

    RomidepsinCisplatinNivolumab

    …of Cisplatin Plus Romidepsin and Nivolumab in Metastatic Triple Negative Breast Cancer or BRCA Mutation-Associated Locally Recurrent or Metastatic Breast Cancer

    Triple-Negative Breast Cancer, Breast Cancer

  99. Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2014 NCT02286687

    Talazoparib FDA EU

    or germline mutation in BRCA1 or BRCA 2 (not breast or ovarian cancer)

    Advanced Malignant Neoplasm, ATM Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation

  100. Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2012 NCT01585805

    CisplatinGemcitabineGemcitabine HydrochlorideVeliparib

    …Gemcitabine, Cisplatin +/- Veliparib in Patients With Pancreas Adenocarcinoma and a Known BRCA/ PALB2 Mutation (Part I) and a Phase II Single Arm Study of Single-Agent Veliparib in Previously Treated …

    Locally Advanced Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8

  101. Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy for Recurrent Epithelial Ovarian Cancer

    Recruiting Phase 1 PhotonPharma Started 2026 NCT06366490

    Innocell Autologous Cellular Immunotherapy

    … therapy likely to convey clinical benefit (i.e., PARP inhibitors for women with germline BRCA mutation and in homologous recombination repair deficiency based on prior molecular testing or bev…

    Ovarian Cancer, Recurrent Epithelial Ovarian Cancer Which Includes Epithelial Ovarian, Fallopian Tube and/or Primary Peritoneal Cancer

  102. Study of CKD-215 and D215 in Adults With BRCA-mutated Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Not yet recruiting Phase 1 Chong Kun Dang Pharmaceutical Started 2026 NCT07532148

    CKD-215D215

    Between 19 aged and 75 aged in patients with advanced BRCA-mutated high-grade epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer

    Ovarian Cancer

  103. Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer

    Recruiting Phase 1 Daewoong Pharmaceutical Started 2026 NCT07371104

    DWZ2501 (Olaparib 150mg) FDA EUDWC202510 (Olaparib 150mg) FDA EU

    Patients with advanced high-grade ovarian cancer harboring a BRCA mutation. 3.

    Cancer, Ovarian Cancer

  104. A Study of PARG Inhibitor FORX-428 in Patients With Advanced Solid Tumors.

    Recruiting Phase 1 FoRx Therapeutics Started 2025 NCT07356453

    FORX-428

    Patients with BRCA1/2 mutations (germline or somatic, pathogenic or likely pathogenic) and other mutations signifying HR …

    Advanced Solid Tumors

  105. Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer

    Recruiting Phase 1 Emory University Started 2025 NCT06324240

    IpilimumabPembrolizumabVaccine Therapy

    Patients who have a germline BRCA 1/2 mutation that meet the Food and Drug Administration (FDA) indication for use of adjuvant Olaparib …

    Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8

  106. Study of SYN818 With Olaparib for the Treatment of Locally Advanced or Metastatic Solid Tumors

    Recruiting Phase 1 Hangzhou SynRx Therapeutics Biomedical Technology Started 2025 NCT07156253

    SYN818 and Olaparib will be administered FDA EU

    …tic solid tumor and has exhausted all standard-of-care treatment options, with documented BRCA mutations and/or homologous recombination repair deficiency (Part 1).

    Metastatic Solid Tumor, Ovarian Cancer, Breast Cancer, BRCA 1 /2 and / or HRD

  107. A Bioequivalence Study to Evaluate Pharmacokinetics and Safety of BR2022 and BR2022-1 in Patients With Deleterious or Suspected Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer

    Recruiting Phase 1 Boryung Pharmaceutical Started 2025 NCT07069335

    Olaparib 150 MG FDA EU

    Patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been t…

    Ovarian Cancer

  108. A Clinical Study of GO306 in Patients With Advanced Solid Tumors

    Recruiting Phase 1 GeneSail Biotech (Shanghai) Started 2025 NCT07128914

    GO306

    …d therapy and no available standard treatment options, and those with germline or somatic BRCA mutations who failed or did not tolerate PARP inhibitors.

    Solid Tumor Malignancies

  109. A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer

    Recruiting Phase 1 AstraZeneca Started 2025 NCT06879041

    AZD2287AZD2275AZD2284

    b)A poly (adp-ribose) polymerase (PARP) inhibitor for participants with known BRCA mutation

    Metastatic Castration-Resistant Prostate Cancer

  110. MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer

    Recruiting Phase 1 Mayo Clinic Started 2024 NCT06483048

    Autologous MUC1-activated T-cellsBendamustineCyclophosphamide

    Patients with BRCA1/2 mutations must have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor t…

    Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Recurrent Fallopian Tube Carcinoma

  111. Study of DM5167 in Patients With Advanced Solid Tumors

    Recruiting Phase 1 DIGMBIO Started 2024 NCT07101601

    DM5167

    Patients who have BRCA1/BRCA2 mutations

    Advanced Breast Cancer

  112. A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)

    Recruiting Phase 1 GSK Started 2024 NCT06431594

    Mocertatug rezetecan

    Participants with known Breast cancer susceptibility gene (BRCA) mutated tumors should have received a Poly adenosine diphosphate-ribose polymerase (PARP) inhibit…

    Solid Tumors, Neoplasms

  113. Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

    Recruiting Phase 1 Dana-Farber Cancer Institute Started 2024 NCT06488378

    AxatilimabOlaparib FDA EU

    Documented germline or somatic mutation in BRCA1, BRCA2, or germline mutation in PALB2 that is predicted to be deleterious or suspected d…

    Breast Cancer, PALB2-Mutated Breast Carcinoma, HER2-negative Breast Cancer, BRCA1 Mutation

  114. A Study of TYK-00540 in Adult Patients With Solid Tumors

    Recruiting Phase 1 TYK Medicines Started 2024 NCT06246071

    TYK-00540

    For patients with documented germline BRCA1/BRCA2 mutations, if they have been treated with an approved PARP inhibitor, then the PARP inhibitor can b…

    Status may be outdated, last updated 2024-02-07Locally Advanced or Metastatic Solid Tumors

  115. CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

    Recruiting Phase 1 Lan Coffman Started 2024 NCT05942300

    CPI-0209carboplatin

    Women with germline BRCA mutations should be considered for PARPi maintenance as standard of care treatment prior to conside…

    Recurrent Ovarian Cancer

  116. A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors

    Recruiting Phase 1 Exelixis Started 2024 NCT05932862

    XL309Olaparib FDA EU

    …R2)-negative breast cancer, with deleterious or suspected deleterious breast cancer gene (BRCA)1/2 alteration.

    Advanced Solid Tumor

  117. Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

    Active, not recruiting Phase 1 Masonic Cancer Center, University of Minnesota Started 2024 NCT06342986

    FT536FludarabineCY

    In the presence of a BRCA mutation, must have received a prior PARP inhibitor.

    Gynecologic Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer

  118. Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes

    Recruiting Phase 1 National Cancer Institute (NCI) Started 2023 NCT05687110

    Novobiocin Sodium

    Patients must have histologically confirmed solid tumor with a known pathogenic mutation in BRCA1/2, PALB2, RAD51C, RAD51D, ATM, BARD1, BLM, BRIP1, CDK12, FANCA, FANCC, FANCD2, FANCE, FA…

    Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm

  119. Clinical Trial of PM54 in Advanced Solid Tumors Patients.

    Recruiting Phase 1 PharmaMar Started 2023 NCT05841563

    PM54

    Deleterious germline BRCA1/2 mutation tumors.

    Advanced Solid Tumor

  120. A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors

    Active, not recruiting Phase 1 Sapience Therapeutics Started 2023 NCT05848739

    ST316FOLFIRI regimen & bevacizumabFruquintinibLonsurf & bevacizumab

    Subjects with TNBC or OC with known BRCA mutations must have been previously treated with or intolerant to Food and Drug Administration (FDA…

    Colon Cancer, Metastatic Colon Cancer

  121. Combination of Olaparib and Navitoclax in Women with HGSC and TNBC

    Active, not recruiting Phase 1 Sunnybrook Health Sciences Centre Started 2022 NCT05358639

    Olaparib tablet FDA EUNavitoclax

    Metastatic TNBC: tumors that are known to have deleterious somatic or germline mutations in BRCA1, BRCA2, or PALB2.

    High Grade Serous Carcinoma, Triple Negative Breast Cancer, Ovarian Cancer

  122. Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer

    Active, not recruiting Phase 1 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2022 NCT05013216

    Cohort A: Patients at high risk of developing pancreatic cancer.Cohort B: Patients must have evidence of a pancreatic cystic neoplasm

    … of the youngest relative with pancreatic cancer, and the Patient is a carrier of a known BRCA2, ATM, PALB2 mutation.

    High Risk Cancer, Pancreatic Cancer

  123. Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation

    Recruiting Phase 1 Senhwa Biosciences Started 2021 NCT04890613

    CX-5461

    Documented evidence of pathogenic or likely pathogenic somatic or germline mutation in BRCA1/2 and/or PALB2, and/or any genetic alterations listed below as indicated in a Clinical L…

    Advanced Solid Tumor

  124. Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer

    Active, not recruiting Phase 1 University of Washington Started 2021 NCT04673448

    DostarlimabNiraparib FDA EU

    …n tube or primary peritoneal cancer that is unresectable or metastatic, with a pathogenic mutation in BRCA1 or BRCA2 (either germline or somatic) as confirmed by next generation gene sequencing su…

    Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, BRCA-Associated Malignant Neoplasm, BRCA Hereditary Ovarian Carcinoma

  125. SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells

    Recruiting Phase 1 General Oncology Started 2021 NCT04150042

    MelphalanBCNUVitamin B12BVitamin C

    For potential subjects with a germline BRCA1, BRCA2, or PALB2 mutation:

    Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation, BRCA2 Mutation, Pancreatic Acinar Cell Carcinoma

  126. Testing the Sequential Combination of the Anti-cancer Drugs Olaparib Followed by Adavosertib (AZD1775) in Patients With Advanced Solid Tumors With Selected Mutations and PARP Resistance, STAR Study

    Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2020 NCT04197713

    AdavosertibOlaparib FDA EU

    Germline or somatic mutations in BRCA1 or BRCA2

    Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm

  127. Olaparib + Sapacitabine in BRCA Mutant Breast Cancer

    Active, not recruiting Phase 1 Dana-Farber Cancer Institute Started 2018 NCT03641755

    SapacitabineOlaparib FDA EU

    Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicte…

    Breast Cancer

  128. Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents

    Active, not recruiting Phase 1 AstraZeneca Started 2014 NCT02264678

    Administration of ceralasertibAdministration of ceralasertib in combination with olaparib FDA EUAdministation of ceralasertib in combination with durvalumabAdministration of ceralasertib monotherapyAdministration of ceralasertib and olaparib FDA EUAdministration of ceralasertib and durvalumab

    Module 5 Part B: known or suspected BRCA mutation, PALB2 mutation, RAD51C/D mutation or HRD positive status

    Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer

  129. Veliparib and Dinaciclib in Treating Patients With Advanced Solid Tumors

    Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2011 NCT01434316

    DinaciclibVeliparib

    Patients enrolling in the BRCA-deficient cohorts must have a documented BRCA1 or BRCA2 germline mutation

    Advanced Malignant Solid Neoplasm

  130. Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer

    Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2010 NCT01251874

    CarboplatinVeliparib

    HER negative with a known germline BRCA1/2 mutation

    Recurrent Breast Carcinoma, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7

  131. Olaparib in Treating Patients With Newly Diagnosed BRCA-Mutant Ovarian, Primary Peritoneal, or Fallopian Cancer Before Surgery

    Active, not recruiting Early Phase 1 M.D. Anderson Cancer Center Started 2019 NCT03943173

    ChemotherapyOlaparib FDA EU

    Olaparib in Treating Patients With Newly Diagnosed BRCA-Mutant Ovarian, Primary Peritoneal, or Fallopian Cancer Before Surgery

    BRCA-Mutated Ovarian Carcinoma, BRCA1 Gene Mutation, BRCA2 Gene Mutation, High Grade Fallopian Tube Serous Adenocarcinoma

  132. Plant-derived Nutrients in the Prevention and Prognosis of Breast Cancer in Women.

    Active, not recruiting No phase Keda Yu Started 2026 NCT07868159

    …e definition of high risk for breast cancer (fulfills at least one criterion): carrier of BRCA1/2 mutations, family history of breast cancer in first-degree relatives, confirmed atypical ductal hyp…

    Breast Cancer

  133. Prevalence of Germline Alterations in Actionable Genes in Endometrial Cancer

    Not yet recruiting No phase European Institute of Oncology Started 2026 NCT07066969

    Sophia DDM

    tumoral BRCA mutation

    Endometrial Cancer

  134. Cohort Evaluation of Body Fluids Early Detection of Cancer in High-risk Individuals

    Recruiting No phase Gustave Roussy, Cancer Campus, Grand Paris Started 2026 NCT06907095

    Women carrying germline pathogenic (P) or likely pathogenic (LP) variants of BRCA1, BRCA2, TP53, PALB2, PTEN, CDH1 genes without prophylactic mastectomy, aged ≥ 40 years, …

    Risk of Breast Cancer, Risk of Gynaecological Cancer, Risk of Colorectal Cancer, Risk of Upper Gastrointestinal Cancers

  135. Uterine Lavage to Detect Ovarian Cancer Risk

    Recruiting No phase University of Washington Started 2026 NCT07772869

    Have a pathogenic BRCA1 or BRCA2 germline variant

    BRCA Hereditary Ovarian Carcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma

  136. Cognitive Behavioral Therapy for Fear of Cancer Recurrence in Women With BRCA1/2 Gene

    Recruiting No phase CHU de Quebec-Universite Laval Started 2026 NCT06817694

    2\) Be known to carry a BRCA1/2 pathogenic mutation.

    Breast Cancer Susceptibility Gene (BRCA1) Mutation, BRCA2 Mutation, Fear of Cancer Recurrence

  137. ACT-GEN (Adherence And Care Tracking In GENetic Cancer Syndromes)

    Not yet recruiting No phase M.D. Anderson Cancer Center Started 2026 NCT07565467

    BRCA1 pathogenic variant or deleterious mutation: ≥ 35 years old

    ACT-GEN, Genetic Cancer Syndromes

  138. Epigenomic and Transcriptomic Analysis in BRCA Mutated Carriers With and Without Serous Tubal Intraepithelial Carcinoma

    Not yet recruiting No phase Fondazione Policlinico Universitario Agostino Gemelli IRCCS Started 2026 NCT07736300

    Documented germline BRCA1/2 pathogenic variant

    Epigenomics, Transcriptomics, BRCA Mutations

  139. Access My Breast Cancer Care App

    Recruiting No phase University of British Columbia Started 2026 NCT07696637

    You have a diagnosis of breast cancer, or a BRCA mutation, and will be -having breast surgery with reconstruction (the app is tailored the breast c…

    Breast Reconstruction, Breast Cancer

  140. Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1/2 Pathogenic Variants

    Not yet recruiting No phase Weill Medical College of Cornell University Started 2026 NCT07764744

    Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1/2 Pathogenic Variants

    Ovarian Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Serous Tubal Intraepithelial Carcinoma

  141. Robotic Nipple Sparing Mastectomy with Immediate Reconstruction

    Not yet recruiting No phase European Institute of Oncology Started 2025 NCT06860217

    …truction for invasive breast cancer, ductal carcinoma in situ (DCIS), BReast CAncer gene (BRCA) mutation carriers

    Breast Cancer, DCIS, BRCA Mutation

  142. Testing an Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing in Young Adults With Cancer

    Recruiting No phase Alliance for Clinical Trials in Oncology Started 2025 NCT07091617

    Given targeted therapies for BRCA+ and microsatellite instability (MSI)-high/Lynch Syndrome patients and benefit to relative…

    Miscellaneous Neoplasm, Nos, Non-Neoplastic Condition, Nos

  143. Detection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy

    Recruiting No phase Institut Claudius Regaud Started 2025 NCT06588322

    …tection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy

    Ovarian Cancer

  144. A Study of Changes in Ki67 Expression in People With Breast Cancer Receiving Endocrine Therapy Before Surgery

    Recruiting No phase Memorial Sloan Kettering Cancer Center Started 2024 NCT06127979

    Differential Changes in Ki67 Between Carriers and Noncarriers of BRCA2 Mutations With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-negative Breast…

    Breast Cancer

  145. A 3D Bioprinted Hormone-producing Model for BRCA Mutated Patients After Risk Reducing Surgery: the DISC-OVARY Trial

    Active, not recruiting No phase Fondazione Policlinico Universitario Agostino Gemelli IRCCS Started 2024 NCT06497270

    A 3D Bioprinted Hormone-producing Model for BRCA Mutated Patients After Risk Reducing Surgery: the DISC-OVARY Trial

    Status may be outdated, last updated 2024-10-23BRCA Mutation, Estrogen Deficiency, Surgical Menopause, Menopause Related Conditions

  146. Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening

    Recruiting No phase Lipidica, a.s. Started 2024 NCT06549725

    Person with APC, ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, PALB2 or TP53 mutation: \> 45 years or 10 years before the diagnosis of PaC in the youngest family member (which…

    Pancreas Cancer, Pancreatic Ductal Adenocarcinoma, Hereditary Diseases, Pancreatitis, Chronic

  147. Prophylactic Irradiation to the Contralateral Breast for BCAs Patients

    Recruiting No phase Second Affiliated Hospital, Zhejiang University, School of Medicine Started 2023 NCT04960839

    Patients with a deleterious germline mutation of BRCA 1/2 or PALB2.

    Status may be outdated, last updated 2021-07-14Breast Cancer

  148. Feasibility Study: IGNITE-TX (Identifying Individuals for Genetic Testing & Treatment) Intervention

    Active, not recruiting No phase M.D. Anderson Cancer Center Started 2023 NCT05677048

    Has known deleterious/pathogenic mutation or suspected deleterious/pathogenic variant in BRCA1 or BRCA2 (HBOC) or MLH1, MSH2, MSH6, PMS2, or EPCAM (LS)

    Gynecologic Cancer, Ovary Cancer, Pancreatic Cancer, Breast Cancer

  149. Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study

    Recruiting No phase M.D. Anderson Cancer Center Started 2022 NCT05287451

    Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and/or RAD51D gene germline mutation.

    Ovarian Cancer, Fallopian Tube Cancer

  150. Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1) Expression as Biomarker of PARP Inhibitor Resistance in Patients With Deleterious Germline Mutation in BRCA 1/2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer.

    Recruiting No phase Institut Claudius Regaud Started 2022 NCT05378204

    Patients, with deleterious germline BRCA 1 and/or 2, in progression under PARPi alone (talazoparib or olaparib)

    Breast Cancer

  151. Interest of Broadband Spectroscopy Analysis by Infrared Laser on Liquid Biopsies in Breast Cancer Screening

    Active, not recruiting No phase Centre Jean Perrin Started 2021 NCT04273542

    woman carrying the BRCA1/2 mutation, followed according to standard recommendations or

    Breast Cancer Female, BRCA1 Mutation, BRCA2 Mutation

  152. TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

    Recruiting No phase University Medical Center Nijmegen Started 2020 NCT04294927

    Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers.

    BRCA1 Gene Mutation, BRCA2 Gene Mutation, RAD51C Gene Mutation, RAD51D Gene Mutation

  153. A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer

    Recruiting No phase NRG Oncology Started 2020 NCT04251052

    …elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm)…

    Ovarian Carcinoma

  154. Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families

    Active, not recruiting No phase M.D. Anderson Cancer Center Started 2017 NCT04125914

    Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families

    Hereditary Breast Carcinoma, Hereditary Ovarian Carcinoma, Lynch Syndrome

  155. Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants

    Active, not recruiting No phase M.D. Anderson Cancer Center Started 2017 NCT03546972

    …owing: Gail model lifetime risk \> 20% or a 5 year risk \>1.66%, a history of deleterious BRCA1/2 mutation or mantle radiation, a history of ductal cancer in situ, or a history of high risk premal…

    Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation, Ductal Breast Carcinoma In Situ, Obesity

  156. Women at Risk of Breast Cancer and OLFM4

    Active, not recruiting No phase Institut Cancerologie de l'Ouest Started 2016 NCT02653105

    OLFM4

    Evaluation of the Circulating Concentration of Olfactomédine 4 (OLFM4) in Women With a BRCA1 or 2 Gene Mutation or at High Risk of Developing Breast Cancer, According to the Imaging

    Hereditary Breast and Ovarian Cancer Syndrome

  157. Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers

    Active, not recruiting No phase University Medical Center Nijmegen Started 2015 NCT02321228

    Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2

    BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ovarian Cancer

  158. Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members

    Active, not recruiting No phase M.D. Anderson Cancer Center Started 2014 NCT02194387

    PILOT II: BRCA positive OR Lynch syndrome positive individuals

    Body Mass Index 25 or Greater, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Breast Carcinoma

  159. Prostate Screening Study Using MRI in BRCA Carriers

    Active, not recruiting No phase Toronto Sunnybrook Regional Cancer Centre Started 2014 NCT01990521

    Prostate Screening Study Using MRI in BRCA Carriers

    Prostate Cancer

  160. Prophylactic Salpingectomy With Delayed Oophorectomy

    Active, not recruiting No phase M.D. Anderson Cancer Center Started 2013 NCT01907789

    Premenopausal women with a documented BRCA1 or BRCA2 mutation.

    Ovarian Carcinoma

  161. Radical Fimbriectomy for Young BRCA Mutation Carriers

    Active, not recruiting No phase Centre Oscar Lambret Started 2012 NCT01608074

    With a BRCA 1 or 2 mutation, or a family history of breast/ovarian cancer

    BRCA1 Mutation, BRCA2 Mutation, Hereditary Breast and Ovarian Cancer

  162. Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer

    Recruiting Phase 3 GOG Foundation Started 2024 NCT05659381

    Cisplatin

    Patients with germline or somatic BRCA or other similar mutations (RAD51C, RAD51D, BRIP1, BARD) are not required to have HRD/LOH…

    Broad match: BRCA1/2 mutationStage III Ovarian Cancer, Stage IV Ovarian Cancer, Stage III Primary Peritoneal Cancer, Stage IV Primary Peritoneal Cancer

  163. Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)

    Active, not recruiting Phase 3 University Health Network, Toronto Started 2021 NCT04874038

    Lidocaine 20mg/ml

    …my, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)

    Broad match: BRCA1/2 mutationPost-mastectomy Pain Syndrome, Breast Cancer, Pain, Postoperative, Pain, Chronic

  164. Clinical Study of ASN-3186 in Patients with Advanced Solid Tumors

    Not yet recruiting Phase 1/2 Jiangsu Yahong Meditech Co., Ltd aka Asieris Started 2025 NCT06787950

    ASN-3186ASN-3186ASN-3186

    …ts: Subjects must have confirmed deleterious or suspected deleterious germline or somatic BRCAm, or HRRm, or HRD positive or other alterations.

    Broad match: BRCA1/2 mutationAdvanced Solid Tumors

  165. Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer

    Recruiting Phase 1 National Cancer Institute (NCI) Started 2021 NCT04633239

    AbemaciclibOlaparib FDA EU

    …ade serous histology is required (for the dose expansion cohort only) (data on BRCA (e.g. germline BRCA, Somatic BRCA, Neither, Unknown) and homologous recombination deficiency (HRD)/Loss of He…

    Broad match: BRCA1/2 mutationRecurrent Ovarian High Grade Serous Adenocarcinoma, Recurrent Platinum-Resistant Ovarian Carcinoma

  166. Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery

    Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2018 NCT03317405

    Endoxifen Hydrochloride

    …py, pathology confirmed stage 0-III (including ductal carcinoma in situ), or prophylaxis (BRCA1/2 mutation carriers, women with strong family history or lobular carcinoma in situ or other conditio…

    Broad match: BRCA1/2 mutationBreast Carcinoma In Situ, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ, Stage I Breast Cancer AJCC v7

  167. Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube

    Active, not recruiting Early Phase 1 University of Oklahoma Started 2019 NCT03771651

    Aspirin 81 mg

    …isk for prevalent fallopian tube cancer (not undergoing risk reducing surgery for a known BRCA mutation or other known hereditary predisposition syndrome, family history of ovarian cancer in a …

    Broad match: BRCA1/2 mutationFallopian Tube Cancer, Fallopian Tube Infection

  168. BREAST Choice Decision Tool R21 - AIM2

    Recruiting No phase UNC Lineberger Comprehensive Cancer Center Started 2024 NCT06817226

    …of breast malignancy (e.g., ductal carcinoma, DCIS) or high risk for breast cancer (e.g., BRCA mutation)

    Broad match: BRCA1/2 mutationBreast Cancer