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

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.

Trial Details

NCT ID

NCT06016738

Phase

PHASE3

Sponsor

Olema Pharmaceuticals, Inc.

Status

RECRUITING

Cancer Type

HER2 Negative Breast Cancer

Interventions

Palazestrant
Fulvestrant
Anastrozole
Letrozole
Exemestane

Locations (sample)

Tucson, Arizona, United States|32.22174,-110.92648
Fountain Valley, California, United States|33.70918,-117.95367
Los Alamitos, California, United States|33.80307,-118.07256
Aurora, Colorado, United States|39.72943,-104.83192
Golden, Colorado, United States|39.75554,-105.2211

Key Eligibility Criteria

Adult female or male participants.
ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
Evaluable disease (measurable disease or bone-only disease).
Previously received a CDK4/6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy…

For full eligibility, visit ClinicalTrials.gov.

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