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.

Disease Sites:

Not Available

Staging:

Phase III

Age Group:

Adults

Therapies:

Hormonal Therapy

Drugs:

Anastrozole, Exemestane, Fulvestrant, Letrozole (Femara), OP-1250

Principal Investigator(s):

Abramson, Vandana

Scope:

International

Participating Institutions:

Vanderbilt University

Open Date:

11-28-2025

Trial Type:

Treatment

Protocol ID:

VICC-DTBRE23292

National Clinical Trial ID:

NCT06016738

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

ALL

Accepts Healthy Volunteers?:

false

Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

Eligibility