Condition: Premenopausal Breast Cancer · Metastatic Breast Cancer · ER Positive Breast Cancer · Sponsor: National Taiwan University Hospital
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/ durvalumab (Arm A), goserelin/ fulvestrant/ capivasertib/ durvalumab (Arm B), or goserelin/ fulvestrant/ capivasertib (Arm C) at a 1:1:1 ratio. The primary endpoint is objective response rate (ORR) of the whole other three arm compared to historical goserelin/ fulvestrantcontrol arm. The major secondary endpoint will be progression-free survival or ORR compared among different treatment arms.
This description comes directly from the study's public registry record.
Yen-Shen Lu, MD, PhD · +886-2-23123456 · yslu@ntu.edu.tw
Always discuss trial participation with your own doctor first.
| Department of Oncology, National Taiwan University Hospital | Taipei, Taiwan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05720260