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

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT06016738
Trial Phases:	Phase III	Protocol IDs:	OP-1250-301 (primary) NCI-2023-09687 OPERA-01
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Olema Pharmaceuticals, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT06016738

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.

Objectives

This is an international, multicenter, randomized, open-label, active-controlled, phase 3
clinical trial. The purpose of this trial is to compare the safety and efficacy of
palazestrant (OP-1250) as a single agent to the standard of care endocrine therapy:
either fulvestrant or an aromatase inhibitor (anastrozole, letrozole, or exemestane).

This trial is seeking adult participants with ER+, HER2- advanced or metastatic breast
cancer whose disease has relapsed or progressed on 1 or 2 prior lines of standard-of-care
endocrine therapy for metastatic breast cancer. Prior lines of therapy must include one
line of endocrine therapy in combination with a CDK 4/6 inhibitor. In the dose-selection
part of the trial, approximately 120 participants will be randomized to one of the two
doses of palazestrant or to the standard-of-care endocrine therapy. Thereafter,
approximately 390 participants will be randomized to palazestrant at the selected dose or
to the standard-of-care endocrine therapy.

Treatment Sites in Georgia

City of Hope Atlanta
600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.