Trial Information

Summary: Randomized Phase II Study of Docetaxel, Adriamycin, and Cytoxan (TAC) Versus Adriamycin/Cytoxan, Followed By Abraxane/Carboplatin (ACAC) +/- Trastuzumab As Neoadjuvant Therapy for Patients with Stage I-III Breast Cancer

You have been asked to participate in this research study because you have stage II or stage III breast cancer (cancer that is larger than 2 centimeters or that has spread to one or more lymph nodes.) The purpose of this study is to compare two neoadjuvant (given before surgery) chemotherapy regimens (Docetaxel, Adriamycin and Cytoxan known as TAC or Adriamycin, Cytoxan followed by Abraxane ^? and Carboplatin known as ACAC) in terms of effectiveness (amount of tumor remaining at the time of surgery) and side effects. The study will also evaluate the effectiveness of adding Trastuzumab (Herceptin^?) to Adriamycin, Cytoxan followed by Abraxane ^? and Carboplatin (ACACT) in subjects with HER-2 positive breast cancer. Researchers will also be looking at the genetic and protein makeup of tumor tissue and blood samples collected before, during and after treatment to define prognosis (expected outcome), evaluate changes that occur during treatment and identify potential future targets of therapy. Your participation in this study is expected to last up to 6 months for chemotherapy, followed by surgery within 4 weeks after the last dose of chemotherapy. After you complete treatment, your disease status will be followed indefinitely.

Patient Inclusion/Exclusion Criteria:

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

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Trial listings updated: September 2, 2008 at 1:44:21 PM