Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (ADJUVANT WIDER)
Early Breast Cancer
About this trial
This is an interventional treatment trial for Early Breast Cancer focused on measuring HR+, HER2-, EBC, Early breast cancer, Premenopausal, Postmenopausal, Male breast cancer, Ribociclib, LEE011, NSAI, ET, Endocrine therapy, Goserelin
Eligibility Criteria
Inclusion Criteria: Participant is an adult, male or female ≥ 18 years of age at the time of informed consent signature. Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer Participant has HER2-negative breast cancer Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene, at the time of informed consent signature, but enrolment should occur within 24 months and the participant has at least 3 years remaining of endocrine adjuvant therapy. Participant is allowed up to 24 months of prior ET with a capping of 1000 participants who have taken prior ET between 12 and 24 months prior to first study treatment (C1D1). Participant should have at least 3 years remaining of planned ET at first treatment dose (C1D1). Patient after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories: anatomic stage group II or III. Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1 or 2. Participant has adequate bone marrow and organ function. Exclusion Criteria: Participant with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery. Participant is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET. Participant has any other concurrent severe and/or uncontrolled medical condition Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality. Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Ribociclib + endocrine therapy
Participants will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily endocrine therapy (ET) for up to 39 cycles. ET consists of: For postmenopausal women: letrozole 2.5 mg orally once daily continuously or anastrozole 1 mg orally once daily continuously. For premenopausal women and men: letrozole 2.5 mg orally once daily continuously or anastrozole 1 mg orally once daily continuously, combined with goserelin 3.6 mg subcutaneously once every 4 weeks or leuprolide 3.75 mg subcutaneously once every 4 weeks