Trial Information

Summary: Phase II Study of Tandem Cycle Dose-Intense Chemotherapy of Mephalan and Carboplatin, Thiotepa, and Cyclophosphamide (STAMP V)+/-Trastuzumab followed by Helical Tomotherapy or Local Regional Radiation Therapy for Stage IV Metastatic and Stage IIIB/C Breast Cancer

You have been asked to participate in this research study because you have inflammatory, high risk, or advanced breast cancer.  The main purpose of this study is to evaluate the feasibility (how easily the treatment can be given) and evaluate the toxicities (side effects) of tandem (two) cycles of chemotherapy with Melphalan and Carboplatin, Thiotepa, and Cyclophosphamide (STAMP V), followed by helical tomotherapy (the radiation treatment field shaped to the tumor) or local regional radiation therapy.  If your tumor expresses the HER-2 protein, you will receive an additional drug, trastuzumab (Herceptin). If your tumor is estrogen and/or progesterone receptor positive, and if indicated, you will be prescribed an additional treatment with an anti-estrogen (hormone-blocker) drug (for example, Tamoxifen).  Researchers will also look at tumor specimens and blood to find out if the effects of the drug differ, depending on the biology of the cancer. Your participation in this study is expected to last 24 months for treatment.  After treatment is over, your medical condition will continue to be followed indefinitely.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: July 7, 2008 at 2:31:13 PM