A Phase I-II Study of Dasatinib plus Paclitaxel in Patients with Metastatic Breast Cancer

Protocol
08-122
Full Title
A Phase I-II Study of Dasatinib in Combination with Weekly Paclitaxel for Patients with Metastatic Breast Carcinoma
Phase
I/II
Purpose

Paclitaxel is a drug commonly used to treat breast cancer. In this study, researchers are evaluating the safety and effectiveness of adding another drug called dasatinib to paclitaxel treatment in women with metastatic breast cancer.

In the phase I portion of the study, they will find the highest dose of dasatinib that can be given safely with paclitaxel in these patients. In the phase II portion, they will assess the effectiveness of the combination against breast cancer.

Dasatinib is approved for the treatment of certain types of leukemia, but it is being evaluated for its effectiveness against other cancers. Laboratory studies have shown that it has an anticancer effect on breast cancer cells. Dasatinib is thought to cause cancer cells to die by inhibiting a protein called SRC. It is a pill that is taken by mouth once daily.

Eligibility

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

  • Patients must have recurrent or progressive locally advanced or metastatic breast cancer.
  • For the phase I portion, patients may have had any number of prior therapies, including chemotherapy, hormonal therapy, trastuzumab, and/or bevacizumab.
  • For the phase II portion, patients must have HER2-negative disease. Patients may have had up to two prior chemotherapy regimens for metastatic disease.
  • At least 3 weeks must have passed since completion of prior therapies and entry into the study, and patients must have recovered from any side effects.
  • 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.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Monica Fornier at 646-888-5240.

Disease(s)
Breast Cancer
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