^
    10d
    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. | N=382 --> 510
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    fulvestrant • letrozole • anastrozole • exemestane • palazestrant (OP-1250)
    10d
    Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=180, Recruiting, Olema Pharmaceuticals, Inc. | N=48 --> 180
    Enrollment change • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    fulvestrant • palazestrant (OP-1250)
    10d
    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. | N=360 --> 1000
    Enrollment change • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Kisqali (ribociclib) • letrozole • palazestrant (OP-1250)
    11d
    OPERA-02: Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=360, Recruiting, Olema Pharmaceuticals, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Kisqali (ribociclib) • letrozole • palazestrant (OP-1250)
    21d
    Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=48, Recruiting, Olema Pharmaceuticals, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    fulvestrant • palazestrant (OP-1250)
    24d
    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.
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Kisqali (ribociclib) • letrozole • palazestrant (OP-1250)
    2ms
    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. | N=370 --> 510
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • ESR1 mutation
    |
    fulvestrant • letrozole • anastrozole • exemestane • palazestrant (OP-1250)
    3ms
    OP-1250-302: Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer (OPERA-02) (2025-522873-12-00)
    P2/3, N=312, Not yet recruiting, Olema Pharmaceuticals Inc.
    New P2/3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Kisqali (ribociclib) • letrozole • palazestrant (OP-1250)
    3ms
    OP-1250-302: Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer (OPERA-02) (2025-522873-12-00)
    P2/3, N=135, Not yet recruiting, Olema Pharmaceuticals Inc.
    New P2/3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    Kisqali (ribociclib) • letrozole • palazestrant (OP-1250)
    4ms
    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)
    5ms
    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)
    6ms
    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)