We're sorry. This study is closed and no longer recruiting participants.
STUDY BASICS
Do you have metastatic HER2-positive breast cancer? If so, you may be able to participate in a research study to find out if adding a drug called neratinib to an approved treatment called trastuzumab emtansine (T-DM1) is safe and effective for women with metastatic breast cancer.
STUDY PURPOSE
Metastatic breast cancer is breast cancer that has spread outside of the breast and lymph nodes to other parts of the body. Trastuzumab emtansine (T-DM1) is a drug that is FDA approved for the treatment of women with HER2-positive metastatic breast cancer. T-DM1 combines a HER-2 targeted treatment and a chemotherapy drug. The purpose of this study is to find out if adding a drug called neratinib to T-DM1 is safe and effective for women with metastatic HER-2 positive breast cancer. Neratinib is an investigational targeted therapy that stops cancer cells from growing by targeting and blocking HER proteins that help cancer cells grow. Neratinib is still being studied and is not FDA approved for use in treating breast cancer.COULD THIS STUDY BE RIGHT FOR YOU?
- Women ages 18 and up
- Diagnosed with metastatic HER2-positive breast cancer
WHAT PARTICIPANTS CAN EXPECT
Participants will receive T-DMI through a vein once every 3 weeks and neratinib tablets by mouth once daily. Study therapy continues unless the cancer gets worse or the participant’s doctor decides treatment should stop. During the course of the study, participants will also have the following tests and assessments: medical history, physical exam, heart function tests, cardiac tests, and scans (CT, PET/CT, or MRI), x-rays, or other imaging tests.IRB: STUDY19050367
- NSABP FB-10: A Phase Ib/II Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) with Neratinib in Women with Metastatic HER2-Positive Breast CancerMEET THE RESEARCHER
Rachel Jankowitz
Rachel C. Jankowitz, MD, is an Assistant Professor in the Division of Hematology/Oncology at the University of Pittsburgh School of Medicine. A graduate of Temple University School of Medicine, Dr. Jankowitz’s research interests include the study of invasive lobular carcinoma (ILC).