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Phase 3
Not Enrolling
Breast Cancer

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Trial Information


OBJECTIVES: I. Compare overall and disease-free survival in patients with operable
adenocarcinoma of the breast treated with 4 courses of preoperative doxorubicin and
cyclophosphamide (AC) alone vs 4 courses of preoperative or postoperative docetaxel (TXT)
following 4 courses of preoperative AC. II. Evaluate whether the addition of preoperative
TXT to preoperative AC results in improved rates of clinical and pathologic locoregional
tumor response. III. Assess whether the addition of preoperative TXT to preoperative AC
results in improved rates of breast conservation. IV. Assess whether postoperative TXT
improves disease-free and overall survival in patients who receive preoperative AC,
especially in certain subgroups of patients (e.g., those with pathologically positive

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(under 50 vs 50 and over), clinical tumor size (less than 2.1 cm vs 2.1-4.0 cm vs greater
than 4.0 cm), clinical nodal status (negative vs positive), and participating center.
Patients are randomized to one of three treatment arms. Arm I: Patients receive doxorubicin
IV followed by cyclophosphamide IV over 30 minutes to 2 hours on day 1 every 21 days for 4
courses. Patients receive oral tamoxifen daily for 5 years, starting on day 1. After
completion of chemotherapy, patients are offered surgery (e.g., lumpectomy with axillary
node dissection, or modified radical mastectomy). Post-operative radiotherapy is given
post-lumpectomy. Arm II: Patients receive doxorubicin IV followed by cyclophosphamide IV
over 30 minutes to 2 hours followed by docetaxel IV over 1 hour on day 1 once every 21 days
for 4 courses. Patients receive oral tamoxifen daily for 5 years, starting on day 1. After
the completion of chemotherapy, surgery is offered (as in arm I). Radiotherapy follows
surgery in post-lumpectomy patients. Arm III: Patients receive doxorubicin IV followed by
cyclophosphamide IV over 30 minutes to 2 hours on day 1 every 21 days for 4 courses.
Patients receive oral tamoxifen daily for 5 years, starting on day 1. After completion of
chemotherapy, surgery is offered (as in arm I). After surgical recovery, docetaxel IV is
given over 1 hour once every 21 days for 4 courses. Radiotherapy follows docetaxel in
post-lumpectomy patients. Chemotherapy is repeated every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity. Patients are followed every 6
months for 5 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 2,400 patients will be accrued for this study within 5

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven invasive adenocarcinoma of
the breast Fine-needle aspiration is acceptable Core or Tru-cut biopsies are preferable No
more than 63 days between initial diagnosis and randomization Tumor palpable on clinical
exam and confined to the breast and ipsilateral axilla If clinically negative axillary
nodes (N0): primary tumor greater than 1 cm (T1c-T3) If clinically positive axillary nodes
(N1): any size primary tumor (T1-3) No N2 disease, i.e., ipsilateral nodes clinically
fixed to one another or to other structures No skeletal pain unless: Bone scan and/or
roentgenologic exam negative for metastatic disease Suspicious findings confirmed as
benign by x-ray, MRI, or biopsy No ulceration, erythema, skin infiltration (complete
fixation), or peau d'orange, or skin edema of any magnitude Tethering or dimpling of skin
or nipple inversion allowed No bilateral malignancy Suspicious contralateral mass proven
benign on biopsy allowed None of the following unless proven benign on biopsy: Suspicious
palpable nodes in contralateral axilla Palpable supraclavicular or infraclavicular nodes
Hormone receptor status: Any status

PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Not specified
Performance status: Not specified Life expectancy: At least 10 years (exclusive of cancer
diagnosis) Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin normal AST/ALT normal Alkaline phosphatase normal Renal: Creatinine
normal Cardiovascular: No active cardiac disease that would preclude doxorubicin, e.g.:
Documented myocardial infarction History of congestive heart failure Angina pectoris
requiring medication Valvular disease with documented cardiac function compromise
Arrhythmia associated with heart failure or cardiac dysfunction Poorly controlled
hypertension, i.e., diastolic blood pressure greater than 100 mm Hg Cardiomegaly on chest
x-ray or ventricular hypertrophy on EKG unless left ventricular ejection fraction at least
45% by MUGA Other: No other malignancy within the past 10 years except: Segmentally
resected lobular carcinoma in situ of the ipsilateral or contralateral breast Effectively
treated nonmelanomatous skin cancer Surgically treated carcinoma in situ of the cervix No
systemic disease that would preclude therapy No psychiatric or addictive disorder that
would preclude informed consent Geographically accessible for follow-up Not pregnant

PRIOR CONCURRENT THERAPY: No prior therapy for breast cancer No prior anthracyclines for
any malignancy No concurrent sex hormones (e.g., birth control pills or ovarian
replacement therapy)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine if 4 cycle of pre-op or post-op Taxotere given after 4 cycles of pre-op AC will more effectively prolong survival (S) than does 4 cycles of pre-op AC alone.

Outcome Time Frame:

Time from randomization to death from any cause.

Safety Issue:


Principal Investigator

Harry D. Bear, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Massey Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 1995

Completion Date:

February 2010

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms



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