Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This is a multi-center, randomized, double-blinded, placebo controlled trial in
pre-menopausal women with advanced breast cancer.
The purpose of this study is to assess the efficacy of Ribociclib (LEE011), as measured by
progression free survival (PFS), in premenopausal women with HR positive, HER2 negative
advanced breast cancer
Phase
Phase 3
Funding Agency/Sponsor
Industrial
Disease
Breast Cancer
Enrollment Eligibility
Inclusion Criteria:
- Patient has advanced (locoregionally recurrent or metastatic) breast cancer not
amenable to curative therapy
- Patient is premenopausal or perimenopausal at the time of study entry
- Patients who received (neo) adjuvant therapy for breast cancer are eligible
- Patient has a histologically and/or cytologically confirmed diagnosis of
estrogen-receptor positive and/or progesterone receptor positive breast cancer
- Patient has HER2-negative breast cancer
- Patient must have either measurable disease or If no measurable disease is present,
then at least one predominantly lytic bone lesion
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patient has adequate bone marrow and organ function
Exclusion Criteria:
- Patient who has received a prior CDK4/6 inhibitor
- Patient is postmenopausal
- Patients who currently have inflammatory breast cancer at screening.
- Patients who received any prior hormonal anti-cancer therapy for advanced breast
cancer, except for ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced breast
cancer prior to randomization.
- Patient has a concurrent malignancy or malignancy within 3 years of randomization,
with the exception of adequately treated basal cell skin carcinoma, squamous cell skin
carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
- Patient with CNS metastases.
- Patient has active cardiac disease or a history of cardiac dysfunction
- Patient is currently using other antineoplastic agents
- Patient is pregnant or nursing or physiologically capable of becoming pregnant and not
using highly effective contraception
Other protocol-defined Inclusion/Exclusion may apply.