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Clinical Trial Active — Not Recruiting Phase III NCT06016738

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

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer — Active Not Recruiting • Phase III • Oncology • NCT06016738.

📅 13 Aug 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT06016738
Start
2023-11-16
Completion
2026-10-31
ClinicaliQ Trial Snapshot
  • OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer — Active Not Recruiting • Phase III • Oncology • NCT06016738.
  • Palazestrant versus standard hormone therapy in advanced breast cancer that's progressed on previous endocrine treatment plus CDK4/6 inhibitor.

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What This Trial Is Studying

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor. Conditions: Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma Interventions: Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane Lead Sponsor: Olema Pharmaceuticals, Inc. Planned Enrollment: 510 participants

Full Trial Details
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Eligibility criteria, protocol, and results when available
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