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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

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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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



- 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.


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

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.

Inclusion Criteria


- Histologically proven infiltrating ductal or lobular breast carcinoma

- Stage II or III disease

- Inflammatory breast cancer allowed

- Hormone-receptor status not specified


- ECOG performance status < 2

- Male or female

- Menopausal status not specified (for female patients)

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin normal (except for patient's with Gilbert's disease)

- Creatinine ≤ 1.2 mg/dL

- Creatinine clearance ≥ 70 mL/min

- Ejection fraction ≥ 50% on MUGA

- No neuropathy ≥ grade 1

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective nonhormonal contraception

- No prior malignant disease within the past 5 years, excluding:

- Squamous cell or basal cell skin carcinoma

- Stage I or in situ cervical carcinoma

- No noninvasive (in situ) breast carcinoma within the past 5 years


- At least 5 years since prior antiestrogen treatment for any indication other than
breast cancer prevention (tamoxifen, raloxifene, or an aromatase inhibitor)

- No prior radiotherapy to the chest wall

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate

Outcome Time Frame:

At the time of surgery within 4 weeks of the end of chemotherapy

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • inflammatory breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • male breast cancer
  • Paget disease of the breast with invasive ductal carcinoma
  • invasive ductal breast carcinoma with predominant intraductal component
  • invasive ductal breast carcinoma
  • medullary ductal breast carcinoma with lymphocytic infiltrate
  • comedo ductal breast carcinoma
  • invasive lobular breast carcinoma with predominant in situ component
  • invasive lobular breast carcinoma
  • mucinous ductal breast carcinoma
  • papillary ductal breast carcinoma
  • tubular ductal breast carcinoma
  • Breast Neoplasms



City of Hope Comprehensive Cancer Center Duarte, California  91010