Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer

Our goal is to develop an induction chemotherapy regimen that will have a pCR rate above 50%
in HER2+ patients without exposing patients to the toxicity of an anthracycline-based
regimen. A minimum of 60 evaluable patients will be accrued to the study. We are assuming an
observed pCR (or near pCR) rate of 70%. Assuming no more than 10% of patients will be
inevaluable for the primary endpoint (pCR), we will have at least 54 evaluable patients. With
this number, we will have 90% power, with a 1-sided alpha error of 0.05, to demonstrate a pCR
rate exceeding 50% for our novel regimen.

Inclusion Criteria:

- Histologically documented adenocarcinoma of the breast

- ANC > 1000 cells

- Female; age > 18; Zubrod PS 0-1

- Platelets > 100,000

- Stage IIA-IIIB disease

- Total bilirubin < or = ULN

- No evidence of metastatic disease Not pregnant or lactating

- No prior systemic therapy for this breast cancer

- Serum Creatinine < 1.5 mg/dl or Creat Cl > 30 ml/min

- Serum ALT < 2.5 x ULN

- ER, PR and HER2 status required

- LVEF (MUGA/echo)WNL

- No baseline > 2 neuropathy

- Hemoglobin > 9.0 gm/dl

- HER2+, defined by IHC 3+ or FISH ratio > 2.0