Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
- 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
- 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
Trial Phase Phase III
Trial Type Treatment
Novartis Pharmaceuticals Corporation
- Primary ID CLEE011E2301
- Secondary IDs NCI-2014-02508, 2014-001931-36, S14-01868
- Clinicaltrials.gov ID NCT02278120