OncoMatch/Clinical Trials/NCT06016738
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
Is NCT06016738 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for breast cancer.
Treatment: Palazestrant · Fulvestrant · Anastrozole · Letrozole · Exemestane — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
Required: ESR1 positive
Disease stage
Metastatic disease required
locally advanced or metastatic breast cancer that is not amenable to curative therapy. Evaluable disease (measurable disease or bone-only disease)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: CDK4/6 inhibitor — in combination with endocrine therapy in the advanced setting
Previously received a CDK4/6 inhibitor in combination with an endocrine therapy in the advanced setting
Cannot have received: chemotherapy
Exception: in the advanced/metastatic setting
Previously received chemotherapy in the advanced/metastatic setting
Cannot have received: estrogen receptor-directed therapy (elacestrant)
Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy
Lab requirements
Blood counts
adequate hematologic function
Kidney function
adequate renal function
Liver function
adequate hepatic function
Adequate hematologic, hepatic, and renal functions
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Clinical Trial Site · Tucson, Arizona
- Clinical Trial Site · Fountain Valley, California
- Clinical Trial Site · Glendale, California
- Clinical Trial Site · La Jolla, California
- Clinical Trial Site · Los Alamitos, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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