A Phase 3, open-label, randomized study to evaluate the efficacy and safety of RLY-2608 + fulvestrant compared with capivasertib + fulvestrant as a treatment for PIK3CA-mutated breast cancer, hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer that has recurred or progressed during or after treatment with a DK4/6 inhibitor
Principal Investigator
Dott.ssa Sara Miano
Contact Information for Access
Phase
FASE III
Status
ATTIVO
Objective of the study
The objective of the study is to compare the efficacy and safety of RLY-2608 plus fulvestrant with those of capivasertib plus fulvestrant in patients with a PIK3CA mutation.
Pathologies
Breast Cancer
Medication
RLY-2608
Who is eligible to participate in the study?
Patients who are 18 years of age or older and who meet the study’s eligibility criteria may participate in this study.
The patient population for this study includes men and women with advanced HR+/HER2- breast cancer (ABC) with PIK3CA mutations who have experienced disease progression during first-line treatment for advanced disease, including a CDK4/6 inhibitor.
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