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.
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)
Disease recurrence during adjuvant endocrine therapy
Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.
Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.
History of allergic reactions to study treatment.
Olema Pharmaceuticals, Inc.
Lead sponsor
Novartis Pharmaceuticals
Collaborator