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)
- Conditions
- advanced breast cancer10006291
- Registration Number
- NL-OMON55670
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
• 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
lab)
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression free survival.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall survival, response, clinical benefit, ECOG performance status,<br /><br>side-effects, result quality of life questinnaires.</p><br>