^
    22d
    OPERA-01: a phase III study of palazestrant for ER+, HER2- advanced breast cancer after CDK4/6 inhibitor therapy. (PubMed, Future Oncol)
    OPERA-01 (NCT06016738) is a phase III study designed to evaluate the safety and efficacy of palazestrant monotherapy compared to SOC ET in patients with ER+, HER2- locally advanced or metastatic breast cancer, regardless of ESR1 mutation status, whose disease advanced following treatment with at least one ET in combination with a CDK4/6i.Clinical Trial Registration: Clinicaltrials.gov NCT06016738. Registered 17 August 2023.
    P3 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ESR1 mutation
    |
    palazestrant (OP-1250)
    2ms
    OPERA-02: Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=1000, Recruiting, Olema Pharmaceuticals, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Kisqali (ribociclib) • letrozole • palazestrant (OP-1250)
    2ms
    OP-1250-002: A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, Olema Pharmaceuticals, Inc. | Trial completion date: Jul 2025 --> Mar 2026 | Trial primary completion date: Jan 2025 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    Ibrance (palbociclib) • palazestrant (OP-1250)
    3ms
    OP-1250-003: Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer (clinicaltrials.gov)
    P1, N=190, Recruiting, Olema Pharmaceuticals, Inc. | Active, not recruiting --> Recruiting | Trial completion date: Sep 2026 --> Jan 2028 | Trial primary completion date: Aug 2026 --> Dec 2027
    Enrollment open • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    everolimus • Piqray (alpelisib) • Kisqali (ribociclib) • palazestrant (OP-1250) • atirmociclib (PF-07220060)
    5ms
    OP-1250-001: A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer (clinicaltrials.gov)
    P1/2, N=153, Completed, Olema Pharmaceuticals, Inc. | Active, not recruiting --> Completed | Phase classification: P2 --> P1/2
    Trial completion • Phase classification
    |
    palazestrant (OP-1250)
    5ms
    OP-1250-003: Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, or Everolimus in ER+, HER2- Breast Cancer (clinicaltrials.gov)
    P1, N=155, Active, not recruiting, Olema Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    everolimus • Piqray (alpelisib) • Kisqali (ribociclib) • palazestrant (OP-1250)
    6ms
    OPERA-02: Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=1000, Not yet recruiting, Olema Pharmaceuticals, Inc.
    New P3 trial
    |
    Kisqali (ribociclib) • letrozole • palazestrant (OP-1250)
    7ms
    Palazestrant, a novel oral Complete Estrogen Receptor Antagonist (CERAN) and Selective Estrogen Receptor Degrader (SERD), in patients with ER+/HER2- advanced or metastatic breast cancer: phase 1/2 study results. (PubMed, Breast Cancer Res)
    Palazestrant demonstrated a manageable safety profile, with antitumor activity observed in patients with heavily pretreated cancers with wild-type and ESR1-mutated BC. These data support the ongoing phase 3 study evaluating palazestrant in patients with ER+ /HER2 - MBC.
    P1/2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    ESR1 mutation
    |
    palazestrant (OP-1250)
    8ms
    OPERA-01: OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=510, Recruiting, Olema Pharmaceuticals, Inc. | Active, not recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    fulvestrant • letrozole • anastrozole • exemestane • palazestrant (OP-1250)
    1year
    OPERA-01: OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=510, Active, not recruiting, Olema Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • ESR1 mutation
    |
    fulvestrant • letrozole • anastrozole • exemestane • palazestrant (OP-1250)
    over1year
    Phase 1b Combo w/ Ribociclib, Alpelisib, or Everolimus (clinicaltrials.gov)
    P1, N=155, Recruiting, Olema Pharmaceuticals, Inc. | N=90 --> 155 | Trial completion date: Aug 2024 --> Jun 2026 | Trial primary completion date: Aug 2024 --> May 2026
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    everolimus • Piqray (alpelisib) • Kisqali (ribociclib) • palazestrant (OP-1250)
    over1year
    OP-1250-002: A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, Olema Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting | N=30 --> 60 | Trial completion date: Dec 2023 --> Jul 2025 | Trial primary completion date: Jan 2023 --> Jan 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Ibrance (palbociclib) • palazestrant (OP-1250)