View clinical trials related to Premenopausal Breast Cancer.
Filter by:PREMIERE parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory window of opportunity study in premenopausal women with primary operable HR+/HER2-negative breast cancer with aiming at evaluating the biological effects of elacestrant with or without triptorelin.
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/ durvalumab (Arm 2), goserelin/ fulvestrant/ capivasertib/ durvalumab (Arm 3), or goserelin/ fulvestrant/ capivasertib (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.
Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®). In these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.