Trial Information

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 II-III Breast Cancer

OBJECTIVES:

Primary

- Compare 2 neoadjuvant chemotherapy regimens (docetaxel, doxorubicin hydrochloride, and
cyclophosphamide [TAC] vs doxorubicin and cyclophosphamide followed by paclitaxel and
carboplatin [ACAC]), in terms of toxicities and effectiveness as defined by the
pathological complete remission rate, in patients with non HER2/neu overexpressing
stage II or III breast cancer.

- Evaluate the probability of achieving a pathological complete remission when adding
trastuzumab (Herceptin®) to ACAC in the subset of patients with HER2/neu overexpressing
stage II or III breast cancer.

Secondary

- Identify prognostic and predictive markers of outcome, recurrence, and targets of
therapy.

OUTLINE: This is a randomized study. Patients with non HER2/neu overexpressing tumors are
randomized to 1 of 2 treatment arms. Patients with HER2/neu overexpressing tumors are
assigned to arm III.

- Arm I: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and
docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.

- Arm II: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1;
treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on
day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel
repeats every 4 weeks for 3 courses.

- Arm III: Patients receive chemotherapy as in arm II. They also receive trastuzumab
(Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.

Within 4 weeks after completion of chemotherapy with or without trastuzumab (Herceptin®),
all patients undergo surgery.

PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.