Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
This is an open-label randomized phase II study in estrogen receptor positive locally
advanced or metastatic breast cancer patients. The main inclusion population are either
luminal subtype B by PAM50 analysis or failed less than 2 lines of hormonal therapy for
locally advanced or metastatic breast cancer. The subjects have to be premenopausal or
perimenopausal and are not allowed to receive any systemic chemotherapy for their locally
advanced or metastatic breast cancer. Eligible subjects will be randomized into goserelin/
fulvestrant (Arm 1, control), goserelin/ fulvestrant/ capivasertib (Arm 2), goserelin/
fulvestrant/ capivasertib/ durvalumab (Arm 3), or goserelin/ fulvestrant/ durvalumab (Arm 4)
at a 1:1:1:1 ratio. The primary endpoint is objective response rate (ORR) of the whole other
three arm compared to goserelin/ fulvestrant control arm. The major secondary endpoint will
be progression-free survival or ORR compared among different treatment arms.