A randomized pre-surgical pharmacodynamics study to assess the biological activity of LEE011 plus letrozole versus single agent letrozole in primary breast cancer (CLEE011A 2201)
- Conditions
- breast cancer10006291
- Registration Number
- NL-OMON40407
- Lead Sponsor
- ovartis Pharma BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
• Female >= 18 years old, with newly diagnosed resectable grade II or grade III invasive breast cancer. No prior therapy for breast cancer.
• Postmenopausal. See protocol page 30 for details.
• Confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive HER2 negative breast cancer.
• Patient has a grade II or grade III invasive breast cancer
• Adequate bone marrow and organ function as defined by laboratory values (See
protocol page 30 for details.
• At least one breast lesion with a diameter of >=1.0 cm by ultrasound, mammography, CT- scan, or MRI.
• ECOG performance status 0 or 1.
• Any prior therapy for breast cancer.
• Known history of HIV infection (testing not mandatory).
• Active cardiac disease or a history of cardiac dysfunction. See protocol page 31 for details.
• Systemic corticosteroids within 1 week prior to starting study drug. See protocol page 31 for exceptions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Changes in Ki-67 levels from baseline to day 15</p><br>
- Secondary Outcome Measures
Name Time Method <p>ECG parameters (e.g. QTc), pharmacodynamic markers (e.g. pRB, p-pR and Cyclin<br /><br>D1), pharmacokinetics.</p><br>