Palazestrant

DRUG7 trials

Sponsors

Olema Pharmaceuticals Inc., Olema Pharmaceuticals, Inc.

Conditions

Advanced Breast CancerAdvanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC)Advanced or Metastatic ER+ HER2- Breast Cancer (mBC)Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)Breast CancerER Positive Breast CancerER+ER-positive Breast Cancer

Phase 1

A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

Active, not recruitingNCT05266105

Olema Pharmaceuticals, Inc.Breast Cancer

Start: 2021-12-10End: 2026-03-31Updated: 2025-11-24

Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer

RecruitingNCT05508906

Olema Pharmaceuticals, Inc.Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer +2

Start: 2022-08-31End: 2028-01-31Target: 190Updated: 2025-10-22

Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors

RecruitingNCT06784193

Olema Pharmaceuticals, Inc.Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC), Advanced or Metastatic ER+ HER2- Breast Cancer (mBC), Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) +3

Start: 2024-12-16End: 2027-08-30Target: 180Updated: 2025-10-10

Phase 3

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

RecruitingNCT06016738

Olema Pharmaceuticals, Inc.Advanced Breast Cancer, Breast Cancer, ER Positive Breast Cancer +2

Start: 2023-11-16End: 2027-09-30Target: 510Updated: 2026-03-13

A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF OP-1250 MONOTHERAPY VS STANDARD OF CARE FOR THE TREATMENT OF ER+, HER2- ADVANCED OR METASTATIC BREAST CANCER FOLLOWING ENDOCRINE AND CDK4/6 INHIBITOR THERAPY (OPERA-01)

RecruitingCTIS2023-505871-63-00

Olema Pharmaceuticals Inc.ER+, HER2- metastatic breast cancer following endocrine and CDK 4/6 inhibitor therapy

Start: 2024-04-08Target: 354Updated: 2025-08-18

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

RecruitingNCT07085767

Olema Pharmaceuticals, Inc.Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma +2

Start: 2025-11-03End: 2032-01-01Target: 1000Updated: 2026-03-16

A phase 3 randomized, double-blind, active-controlled study of palazestrant with ribociclib versus letrozole with ribociclib for the first-line treatment of ER+, HER2- advanced breast cancer (OPERA-02)

Not yet recruitingCTIS2025-522873-12-00

Olema Pharmaceuticals Inc.ER+, HER2- Advanced Breast Cancer

Target: 184Updated: 2026-02-18

Related Papers

OPERA-01: a phase III study of palazestrant for ER+, HER2- advanced breast cancer after CDK4/6 inhibitor therapy.

2025-12-29

Abstract P2-09-16: A Phase 1b/2 study of palazestrant (OP-1250) in combination with ribociclib, in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-), advanced or metastatic breast cancer

Clinical Cancer Research2025-06-13

OPERA-01: A randomized, open-label, phase 3 study of palazestrant (OP-1250) monotherapy vs standard-of-care for ER+, HER2- advanced or metastatic breast cancer patients after endocrine therapy and CDK4/6 inhibitors.

Journal of Clinical Oncology2025-05-281 citations

OPERA-01: A randomized, open-label, phase 3 study of palazestrant (OP-1250) vs standard-of-care for patients with ER+, HER2- advanced or metastatic breast cancer after endocrine therapy and CDK4/6 inhibitors.

Journal of Clinical Oncology2024-08-10

OPERA-01: A randomized, open-label, phase 3 study of palazestrant (OP-1250) vs standard-of-care for ER+, HER2- advanced or metastatic breast cancer patients after endocrine therapy and CDK4/6 inhibitors.

Journal of Clinical Oncology2024-06-016 citations

Abstract PO4-04-12: A Phase 1b/2 study of palazestrant (OP-1250) in combination with ribociclib or alpelisib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, advanced and/or metastatic breast cancer

Cancer Research2024-05-021 citations

212P A phase Ib/II study of palazestrant (OP-1250) in combination with ribociclib in patients with estrogen receptor-positive human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer

ESMO Open2024-05-016 citations

A phase 1b/2 dose escalation and expansion study of OP-1250 in combination with ribociclib or alpelisib in patients with advanced and/or metastatic estrogen receptor–positive (ER+)/HER2-negative (HER2-) breast cancer.

Journal of Clinical Oncology2023-06-019 citations

Abstract P3-07-15: Preliminary data from a Phase 1b dose escalation study of OP-1250, an oral CERAN, in combination with palbociclib in patients with advanced and/or metastatic estrogen receptor (ER)-positive, HER2-negative breast cancer

Cancer Research2023-03-011 citations