OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
510 patients around the world
Available in Argentina, United States
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.