A Phase II Study of Gemcitabine plus HER2-Targeting Therapies in Women with Persistent HER2-Positive Advanced Breast Cancer

Full Title

Phase II Study of Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer after Prior Trastuzumab/Pertuzumab-Based Therapy

Purpose

Trastuzumab (Herceptin), pertuzumab (Perjeta), and trastuzumab emtansine (Kadcyla) are anticancer drugs for breast cancer that produces high levels of HER2, a protein on the surface of some breast cancer cells that provides messages telling these cells to grow. In some patients, however, the cancer continues to grow despite treatment with these drugs.

In this study, researchers want to see if adding the chemotherapy drug gemcitabine to trastuzumab and pertuzumab is safe and effective in women with advanced HER2-positive breast cancer who have had prior treatment with trastuzumab, pertuzumab, and trastuzumab emtansine. Gemcitabine is a commonly used chemotherapy drug. All of these drugs are given intravenously (by vein).

Eligibility

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

  • Patients must be women with metastatic HER2-positive breast cancer who were previously treated with trastuzumab, pertuzumab, and trastuzumab emtansine.
  • Patients may not have had more than three regimens of chemotherapy for metastatic cancer. If they already received gemcitabine, it may not have been combined with pertuzumab.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Chau Dang at 646-888-5426.

Protocol

14-124

Phase

II

Investigator

Co-Investigators

Diseases