Clinical Trial NU 13B06
- A Phase I Study of BYL719 and Trastuzumab-MCC-DM1 in HER2-Positive Metastatic Breast Cancer Patients with Progression on Prior Trastuzumab and Taxane-Based Therapy
- Principal Investigator
- Sarika Jain
- Status: SUSPENDED
- Study Type: Therapeutic, Treatment
- Protocol No:.NU 13B06
- The purpose of this study is to see whether a combination of two different drugs - trastuzumab-MCC-DM1 (T-DM1) and BYL719 is safe, and if it might be effective in treating metastatic breast cancer.
- T-DM1 is a type of drug that contains an antibody (trastuzumab) linked to chemotherapy. Antibodies are molecules that can target certain types of cells in the body. The antibody in T-DM1 targets a marker on breast cancer cells called HER2, which allows the drug to go directly to the cancer cells. T-DM1 is approved by the Food and Drug Administration (FDA) for treatment of metastatic breast cancer that has the HER2 marker (HER2 positive). The use of T-DM1 in this study is considered standard treatment for the type of cancer in this study. Unfortunately, some cancers become resistant to therapy. Participants in this study have already been treated with trastuzumab and chemotherapy in the past, and their cancer has gotten worse in spite of those treatments. BYL719 is an oral drug (taken by mouth) that the researchers think may help T-DM1 to work better. BYL719 is not approved by the FDA; therefore, in this study, it is considered investigational (which means it is part of a research study).
Some of the eligibility criteria include:
- Participants must have locally advanced or metastatic breast cancer (cancer that has spread beyond the breast).
- Participants must have breast cancer that is HER2-positive.
- Participants must be age 18 years or older.
- Participants must have had progression (gotten worse) while on a trastuzumab and taxane-based chemotherapy regimen.
- Description of Treatment
- Participants in this study will receive IV infusions of T-DM1 approximately every 21 days (21 days = 1 cycle of treatment). In addition, participants will also take BYL719 by mouth every day. Participants may continue to receive both study treatments until a) their cancer gets worse, b) they experience serious side effects, or c) they and/or the doctor feel it is best for the participants to stop study treatments.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 26-Feb-15 06:27 PM
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