Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Condition: Advanced Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: LEE011; Tamoxifen; Letrozole; Anastrozole; Goserelin; LEE011 Placebo
Intervention description: LEE011 600 mg daily oral; tamoxifen 20 mg daily oral; letrozole 2.5 mg daily oral; anastrozole 1 mg daily oral; Goserelin 3.6 mg subcutaneous injection; LEE011 placebo 600 mg daily oral
Intervention MeSH terms: Tamoxifen; Letrozole; Anastrozole; Goserelin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 672.0
Sex: Female
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: No
Keywords: LEE011; ribociclib; HR-positive; HER2-negative; Advanced breast cancer; Letrozole; Anastrozole; Tamoxifen; Goserelin; CDK; CDK4; CDK6; CDK4/6; Phase III; ER-positive; PR-positive; Premenopausal

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
    

Eligibility criteria:

        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.