NL-OMON55670CompletedPhase 3
A randomized double-blind, placebo-controlled study of LEE011 in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease (CLEE011A2301) - CLEE011A2301 - MONALEESA-2
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- ovartis
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Women >=18 years old, with advanced breast cancer.
- •No prior therapy for advanced disease
- •Postmenopausal. See protocol page 34 for details.
- •Confirmed diagnosis of estrogen-receptor positive and/or progesterone
- •receptor positive, HER2 negative breast cancer.
- •Measurable disease or at least one predominantly lytic bone lesion.
- •ECOG performance status 0 or 1.
- •Adequate bone marrow and organ function (based on central
Exclusion Criteria
- •Received any CDK4/6 inhibitor.
- •Any prior systemic anti-cancer therapy (including hormonal therapy and
- •chemotherapy) for advanced breast cancer. See protocol page 45 for details.
- •Known history of HIV infection (testing not mandatory).
- •Patient has CNS metastases
- •Active cardiac disease or a history of cardiac dysfunction. See protocol page
- •46 for details.
- •Prohibited medication. See protocol page 36 for details.
Investigators
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