USO 25113
A phase 3 randomized, double-blind, active-controlled study of palazestrant with ribociclib versus letrozole with ribociclib for the first-line treatment of ER+, HER2- advanced breast cancer (OPERA-02) OP-1250-302
Disease Types: Breast Cancer Research
Eligibility Requirements:
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.
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