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
The purpose of this study is to determine if the drug, LEE011 is safe and effective when taken with letrozole, by postmenopausal women with hormone receptor-positive advanced breast cancer. Letrozole is an approved drug for the treatment of breast cancer. LEE011 is an investigational drug intended to block certain proteins called cyclin-dependent kinases that are required for cells to divide. These proteins may also control the ability of breast cancer cells to grow. LEE011 has not been approved by FDA; however, the FDA is allowing the use of LEE011 in this study.
Postmenopausal women with hormone receptor positive, HER2 negative advanced breast cancer may be eligible to join this study.
If you agree to participate in this study, you will sign a consent form and undergo baseline testing to make sure it is safe for you to join. This testing will include blood and urine samples, EKG and scans. Once your eligibility has been confirmed, you would be randomized to receive either LEE011 or placebo along with letrozole. A placebo is a capsule with no medicine inside (like a dummy pill) that will look similar to the LEE011 capsules. Neither you nor your doctor will know which you are taking.You will take letrozole by mouth every day. LEE011 or placebo will be taken by mouth every day for 3 weeks (days 1-21 of each 28 day cycle) and then you will take a 7 day rest with no LEE011 or placebo (days 22-28). You may continue on the study as long as you are tolerating the study drugs and your cancer is responding.While on study, you will have clinic visits with blood work, EKGs, and physical exams at the beginning of each cycle (including two weeks after starting treatment). Scans will be repeated every 8 weeks to monitor your disease. You will be asked to complete quality of life questionnaires and other research blood tests during the study.
09/22/2014 04:03 AM