A Phase I Study of Intermittent Lapatinib and Capecitabine in Women with HER2-Positive Breast Cancer that Spread to the Brain

Full Title

Phase I Study of Intermittent High-Dose Lapatinib in Tandem with Capecitabine for HER2 Overexpressed/Amplified Metastatic Breast Cancer with Central Nervous System (CNS) Metastases

Purpose

Lapatinib is a drug used to treat breast cancers that overproduce a protein called HER2. Capecitabine is another drug used to breast cancer that has spread (metastasized) to another part of the body. Both drugs have been shown to have some effectiveness in treating breast cancer that has metastasized, including metastases to the brain.

To optimize the effectiveness of the combination of these two drugs, researchers in this study want to find the highest dose of lapatinib that can be given safely and intermittently with capecitabine over a four-week period in women with previously treated HER2-positive breast cancer that spread to the brain.

Patients will receive lapatinib for three days during each of weeks one and three, and capecitabine for seven days in each of weeks two and four. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have HER2-positive breast cancer that spread to the brain and was previously treated with trastuzumab (Herceptin) or chemotherapy.
  • Patients must recover from the serious side effects of prior treatments before entering the study. Prior capecitabine treatment is permitted if the last dose was given at least 6 months earlier.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Andrew Seidman at 646-888-4559.

Protocol

15-278

Phase

I

Investigator