palbociclib

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

Biomarkers

Sponsors

Industry sponsors leading active biomarker-selected trials of palbociclib.

1. Roche 2
2. AstraZeneca 2
3. Amgen 1
4. Eli Lilly 1
5. KymaThera 1
6. Pikavation Therapeutics 1
7. Stemline Therapeutics 1
8. Totus Medicines 1
9. Relay Therapeutics 1

Trials

15 of 36 trials shown

1. A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

   Recruiting Phase 3 Eli Lilly Started 2025Primary completion 2029-05 NCT07174336

   STX-478ribociclibpalbociclib FDA EUabemaciclibanastrozoleletrozoleExemestanefulvestrant FDA EU

   Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.

   PIK3CA activating mutationBreast Neoplasms, Neoplasm Metastasis

2. 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 2024Primary completion 2029-12 NCT06380751

   saruparibcamizestrantabemaciclibribociclibpalbociclibfulvestrantletrozoleanastrozoleExemestane

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

   BRCA1/2 mutationAdvanced Breast Cancer

3. Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

   Active, not recruiting Phase 3 AstraZeneca Started 2021Primary completion 2025-06 NCT04964934

   camizestrant FDAanastrozoleletrozolepalbociclibabemaciclib FDALuteinizing hormone-releasing hormone (LHRH) agonistribociclib

   Have an ESR1 mutation in their cancer;

   ESR1 mutationER-Positive HER2-Negative Breast Cancer

4. A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

   Active, not recruiting Phase 2/3 Roche Started 2020Primary completion 2023-09 NCT04191499

   inavolisib FDA EUpalbociclib FDA EUfulvestrant FDA EU

   …b + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

   PIK3CA activating mutationBreast Cancer

5. A Phase 1/2a Study of K-1728 in Advanced Solid Tumors

   Not yet recruiting Phase 1/2 KymaThera Started 2026Primary completion 2028-09 NCT07861932

   K-1728fulvestrant FDA EUpalbociclib FDA EU

   Documented activating PIK3CA mutation

   PIK3CA activating mutationBreast Neoplasms, Solid Tumors, PIK3CA Gene Mutation

6. SNV4818 in Participants With Advanced Solid Tumors

   Recruiting Phase 1/2 Pikavation Therapeutics Started 2025Primary completion 2027-04 NCT06736704

   SNV4818fulvestrant FDA EUpalbociclib FDA EU

   Advanced or metastatic solid tumor with an activating PIK3CA mutation.

   PIK3CA activating mutationAdvanced Solid Tumors

7. Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial

   Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2023Primary completion 2028-08 NCT05554367

   binimetinibpalbociclib

   Patients must have KRAS/NRAS/HRAS or RAF mutations or rare RAF fusions as determined by the ComboMATCH screening assessment

   KRAS G12DExocrine Pancreas Carcinoma, Malignant Solid Neoplasm, Ovarian Low Grade Serous Adenocarcinoma, Stage IV Ovarian Cancer AJCC v8

8. Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

   Active, not recruiting Phase 1/2 Stemline Therapeutics Started 2023Primary completion 2026-12 NCT05563220

   elacestrantalpelisib FDA EUeverolimusribociclibpalbociclib FDA EUcapivasertib FDA EUabemaciclib

   Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation by local laboratory assessment.

   PIK3CA activating mutationBreast Cancer, Metastatic Breast Cancer

9. Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer

   Recruiting Phase 2 Northwestern University Started 2023Primary completion 2028-07 NCT06062498

   elacestrant FDA EUpalbociclibabemaciclib FDAribociclib

   Patients must have a confirmed ESR1 mutation.

   ESR1 mutationEstrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer

10. PLATFORM Study of Precision Medicine for Rare Tumors

    Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2020Primary completion 2026-07 NCT04423185

    aumolertinibdacomitinib FDA EUalectinibcrizotinibpyrotinibimatinibniraparibpalbociclibvemurafenibsintilimabatezolizumab

    when obtaining EGFR mutation, ALK fusion, ROS-1 fusion, C-MET amplification, C-MET mutation, BRAF mutation, BRCA1/2 mu…

    EGFR exon 19 deletion / L858RBRAF V600EBRCA1/2 mutationALK fusionROS1 fusionRare Tumor

11. PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer

    Active, not recruiting Phase 2 Washington University School of Medicine Started 2013Primary completion 2021-04 NCT01723774

    palbociclib FDA EUanastrozoleGoserelin

    Pre-registration PIK3CA Mutant Inclusion

    PIK3CA activating mutationBreast Neoplasms

12. A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer

    Recruiting Phase 1 Totus Medicines Started 2023Primary completion 2027-12 NCT05683418

    TOS-358fulvestrant FDA EUpalbociclib FDA EUribociclib

    Known PIK3CA mutations or amplifications as determined at a CAP/CLIA-certified or equivalently accredited diagno…

    PIK3CA activating mutationHR+/HER2-negative Breast Cancer

13. First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

    Recruiting Phase 1 Relay Therapeutics Started 2021Primary completion 2027-04 NCT05216432

    RLY-2608fulvestrant FDA EUpalbociclib FDA EUribociclibPF-07220060 100mgPF-07220060 300 mg

    One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor per local assessment

    PIK3CA activating mutationPIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer

14. Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

    Active, not recruiting Phase 1 Amgen Started 2019Primary completion 2026-12 NCT04185883

    sotorasib FDA EUtrametinibvociprotafibafatinibpembrolizumabpanitumumab FDAcarboplatinpemetrexeddocetaxelpaclitaxelatezolizumabpalbociclib

    Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requireme…

    KRAS G12CAdvanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation

15. To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer

    Active, not recruiting Phase 1 Roche Started 2016Primary completion 2026-12 NCT03006172

    inavolisib FDA EUfulvestrant FDA EUletrozolepalbociclib FDA EUmetformintrastuzumabpertuzumab

    Locally advanced, recurrent, or metastatic, PIK3CA mutant, incurable solid tumor malignancy, including breast cancer

    PIK3CA activating mutationBreast Cancer, Solid Tumor

No trials match these filters.