Breast Cancer Clinical Trial
Official title:
A Phase II Study of Rapamycin (Rapamune, Sirolimus) and Trastuzumab (Herceptin) for Patients With HER-2 Receptor Positive Metastatic Breast Cancer
Rapamune (generic name: Sirolimus®) is a drug that has been approved by the Food and Drug
Administration (government) for use in patients receiving a kidney transplant to prevent the
patient's body from rejecting the transplanted kidney. It has shown antitumor effects in the
laboratory, but has not been approved at this time for the treatment of cancer. Herceptin is
a new form of chemotherapy that has been approved by the Food and Drug Administration for
the treatment of breast cancer.
This study is designed to evaluate the effect and safety of combining Rapamune and Herceptin
on breast cancer. Rapamune and Herceptin are being combined because results from our
laboratory studies suggest that the combination of the two drugs is superior to either drug
used alone. Results from laboratory studies performed at other institutions suggest that
adding Rapamune to Herceptin may also reverse the resistance to Herceptin. Although there
has been extensive experience using Herceptin alone and Rapamune alone in human subjects,
the combination of Herceptin and Rapamune has not been previously evaluated. In addition, we
hope to better understand how these treatments work against an individual woman's tumor by
analyzing tissue samples before, and during treatment.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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