marked.bio

aromatase inhibitor · small molecule

anastrozole

7 active trials across 6 of our biomarkers, targeting aromatase. Not approved for any biomarker on marked.bio yet.

Also known as Arimidex.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
PIK3CA activating mutation 3 4 Phase 3
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 2 2 Phase 2
BRCA1/2 mutation 1 2 Phase 3
ESR1 mutation 1 2 Phase 3
ALK fusion 0 1 –
EGFR exon 19 deletion / L858R 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of anastrozole.

  1. AstraZeneca 3
  2. Eli Lilly 2

Trials

7 of 11 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. Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer

    Recruiting Phase 2 Jonsson Comprehensive Cancer Center Started 2020Primary completion 2026-12 NCT04553770

    anastrozoletrastuzumab deruxtecan FDA EU

    Tumor is HER2-low by immunohistochemistry (IHC), defined as 1+ or 2+, confirmed by central testing (central…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Early-stage Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Invasive Breast Cancer, Stage II Breast Cancer

  5. 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

  6. A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

    Active, not recruiting Phase 1 Eli Lilly Started 2022Primary completion 2025-04 NCT05307705

    LOXO-783fulvestrant FDA EUimlunestrantabemaciclibanastrozoleletrozolepaclitaxel

    … H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)

    PIK3CA activating mutationBreast Cancer

  7. A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

    Active, not recruiting Phase 1 AstraZeneca Started 2020Primary completion 2023-08 NCT04556773

    trastuzumab deruxtecan FDA EUdurvalumabpaclitaxelcapivasertibanastrozolefulvestrantcapecitabine

    Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Metastatic Breast Cancer