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Phase II Study of Taxotere, Doxorubicin and Cyclophosphamide (TAC) Primary Therapy in Stage III Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Phase II Study of Taxotere, Doxorubicin and Cyclophosphamide (TAC) Primary Therapy in Stage III Breast Cancer

OBJECTIVES: I. Determine the clinical response rate to docetaxel, doxorubicin, and
cyclophosphamide as primary therapy in women with stage III breast cancer. II. Determine the
pathologic complete response rate to this treatment regimen in this patient population. III.
Assess the side effects and toxicity profile of this treatment regimen in these patients.

OUTLINE: This is an open label, multicenter study. Patients receive doxorubicin IV over 5-10
minutes followed by cyclophosphamide IV over 5-10 minutes and docetaxel IV over 1 hour.
Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or
unacceptable toxicity. Within 5 weeks following completion of chemotherapy, operable
patients achieving complete or partial response undergo mastectomy, segmental mastectomy, or
lumpectomy with nodal dissection. Patients with positive surgical tumor margins may undergo
an additional surgical procedure. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1 year.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed previously untreated,
stage III adenocarcinoma of the breast At least one bidimensionally and/or
unidimensionally measurable lesion No evidence of disease outside the breast or chest
wall, except for ipsilateral axillary lymph nodes Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic:
Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin
no greater than upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline
phosphatase no greater than 5 times ULN No acute hepatitis Renal: Creatinine no greater
than 1.5 mg/dL No uncontrolled hypercalcemia Cardiovascular: No congestive heart failure
LVEF normal No angina pectoris No uncontrolled cardiac arrhythmias No other significant
heart disease No myocardial infarction within the past year No superior vena cava syndrome
No deep vein thrombosis requiring anticoagulant therapy Neurologic: No dementia No
seizures No concurrent grade 2 or greater peripheral neuropathy Other: No medical
instability No active infection No gastrointestinal bleeding No uncontrolled diabetes No
psychological, familial, sociological, or geographical conditions or other circumstances
that would preclude study No other malignancy within the past 5 years except curatively
treated basal cell skin cancer or carcinoma in situ of the cervix No history of
hypersensitivity to polysorbate 80 Not pregnant or nursing Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for breast cancer
Chemotherapy: No prior chemotherapy for breast cancer Endocrine therapy: No prior hormonal
therapy for breast cancer No concurrent corticosteroids except for chronic
methylprednisolone or equivalent for more than 6 months duration at no more than 20 mg/day
Radiotherapy: Not specified Surgery: Not specified Other: At least 3 weeks since prior
investigational drugs

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

William J. Gradishar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:

NU 98B1



Start Date:

November 1998

Completion Date:

June 2005

Related Keywords:

  • Breast Cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms



Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
Stanford University Medical Center Stanford, California  94305-5408
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
Monroe Medical Associates Chicago, Illinois  60603