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Advanced Breast Cancer / Metastatic Breast Cancer / Letrozole · Phase 3 Trial
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 3 randomized trial comparing palazestrant to standard-of-care endocrine therapies (fulvestrant or aromatase inhibitor) in advanced ER+/HER2− breast cancer. No results are yet posted in this registry record, so the efficacy and safety of palazestrant remain unknown and cannot be assessed.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma; age from 18 Years. Intervention: Palazestrant (OP-1250). Compared with: Standard of Care Endocrine Therapy — Active Comparator. n = 510. 233 sites across 26 countries.
This is a registered Phase 3 randomized trial comparing palazestrant to standard-of-care endocrine therapies (fulvestrant or aromatase inhibitor) in advanced ER+/HER2− breast cancer. No results are yet posted in this registry record, so the efficacy and safety of palazestrant remain unknown and cannot be assessed.
No data on efficacy, safety outcomes, effect sizes, or confidence intervals are available.
Clinicians cannot yet act on this trial, as no results are reported. Once data become available, this trial may inform treatment decisions for endocrine-resistant advanced breast cancer if palazestrant shows superior PFS or favourable tolerability.
This is a registry record for an ongoing Phase 3 trial with no results yet reported; the study design is sound but evidence cannot be evaluated until data are available.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians cannot yet act on this trial, as no results are reported. Once data become available, this trial may inform treatment decisions for endocrine-resistant advanced breast cancer if palazestrant shows superior PFS or favourable tolerability.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06016738). This is a study registration, not published results. Lead sponsor: Olema Pharmaceuticals, Inc.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 510 participants (ESTIMATED). Conditions: Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma. Interventions: DRUG: Palazestrant; DRUG: Fulvestrant; DRUG: Anastrozole; DRUG: Letrozole; DRUG: Exemestane. Primary outcome measures: Dose-Selection Part: Incidence of adverse events , From Date of Randomization up to 16 weeks; Dose-Selection Part: Incidence of dose reduction , From Date of Randomization up to 16 weeks; Dose-Selection Part: Incidence of drug discontinuation , From Date of Randomization up to 16 weeks; Trial: Progression-Free Survival (PFS) , From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 2 years). Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.