Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
Breast Cancer
Unknown Primary
18 Years and older, Male and Female
OP-1250-302 (primary)
NCI-2026-02023
OPERA-02
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.
Eligibility
- Adult female or male participants.
- ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
- Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).
- De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic, hepatic, and renal functions.
- Female participants can be pre-, peri- or postmenopausal.
- Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.
Treatment Sites in Georgia
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