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.
Signed informed consent must be obtained prior to any trial-specific procedure.
Female patients who are at least 35 years of age on the day of signing informed consent.
Patient is premenopausal at the time of study entry
Patient had last menstrual period within the last 6 months. OR
Inoperable locally advanced or inflammatory breast cancer (any stage III).
Metastatic (Stage IV) breast cancer.
Synchronous invasive bilateral or multicentric breast cancer.
Patients requiring immediate neoadjuvant chemotherapy or immediate surgical intervention.