Study on LEE011, BYL719, and Letrozole for Advanced ER+ Breast Cancer
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT01872260
This clinical trial is testing a combination of two investigational drugs, LEE011 and BYL719, with Letrozole to treat advanced estrogen receptor-positive (ER+) breast cancer. The study aims to find the best dose and evaluate the safety and effectiveness of these drug combinations.
Patient Parameters
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Program Overview
The trial is designed to explore the potential of two new drugs, LEE011 and BYL719, in combination with Letrozole, for treating advanced ER+ breast cancer. It involves multiple centers and is open-label, meaning both doctors and participants know which treatments are being administered. The study will first determine the best dose for the drug combinations and then expand to further assess their safety and effectiveness. Approximately 270 women with ER+/HER2- advanced breast cancer will participate.
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive breast cancer.
- For the initial phase, any number of previous hormone therapies is allowed, except for one prior chemotherapy in advanced cancer.
- For later phases, no prior treatments for advanced cancer, except for up to one month of Letrozole before starting the study.
- Women who had previous breast cancer treatments are eligible if they had a disease-free period of more than 12 months after completing Letrozole or Anastrozole therapy.
Exclusion Criteria
- Tumors with HER2 overexpression.
- Active cancer spread to the brain or central nervous system.
- Major surgery within the last two weeks.
- Current or past pancreatitis.
- Widespread cancer in the lungs.
- Another cancer within the last three years.
- Ongoing hormone replacement therapy that cannot be stopped.
- Heart problems.
- Diabetes that is currently treated or has specific blood sugar levels.
- Other specific criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Univ of California at San Diego Moores Cancer Ctr | 92103 | San Diego | California |
| UCSF Medical Center | 94143 | San Francisco | California |
| H Lee Moffitt Cancer Center and Research Institute | 33612 | Tampa | Florida |
| Massachusetts General Hospital SC-5 | 02114 | Boston | Massachusetts |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Sarah Cannon Research Institute | 37203 | Nashville | Tennessee |
| Vanderbilt University Medical Ctr | 37232 | Nashville | Tennessee |
| Texas Oncology | 75246 | Dallas | Texas |
| Mays Cancer Ctr Uthsa Mdacc | 78229 | San Antonio | Texas |
| Northwest Medical Specialties | 98405 | Tacoma | Washington |
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