Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT07085767
Trial Phases:	Phase III	Protocol IDs:	OP-1250-302 (primary) NCI-2026-02023 OPERA-02
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Olema Pharmaceuticals, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT07085767

Summary

This phase 3 clinical trial compares the efficacy and safety of palazestrant with
ribociclib to letrozole and ribociclib in women and men who have not received prior
systemic anti-cancer treatment for advanced breast cancer.

Objectives

This is an international, multicenter, randomized, double-blind, active-controlled, phase
3 clinical trial. The purpose of this trial is to compare the efficacy and safety of
palazestrant in combination with ribociclib +letrozole -matching placebo (Arm A:
investigational arm) with letrozole in combination with ribociclib +
palazestrant-matching placebo (Arm B: control arm).

This trial is seeking adult participants with ER+, HER2- advanced breast cancer who have
not received prior systemic anti-cancer treatment for advanced disease. Approximately
1,000 participants will be randomized in a 1:1 ratio to one of the two study arms.

Treatment Sites in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

**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.