A Randomised Comparative Trial of Adriamycin + Taxotere vs. Adriamycin + Cyclophosphamide as Primary Medical Therapy for Patients With Potentially Operable Breast Cancer Greater Than or Equal to 3 cm Diameter, Locally Advanced, or Inflammatory Disease
18 Years
60 Years
Female
Breast Cancer
Trial Information
A Randomised Comparative Trial of Adriamycin + Taxotere vs. Adriamycin + Cyclophosphamide as Primary Medical Therapy for Patients With Potentially Operable Breast Cancer Greater Than or Equal to 3 cm Diameter, Locally Advanced, or Inflammatory Disease
OBJECTIVES: I. Compare the efficacy (response rate) and toxicity of doxorubicin in
combination with either docetaxel or cyclophosphamide as primary therapy regimens in
patients with locally advanced or inflammatory breast cancer.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to participating center and operability. Patients are randomized to one of two
treatment arms. Arm I: Patients receive docetaxel IV followed by doxorubicin IV once every 3
weeks. Arm II: Patients receive doxorubicin IV and cyclophosphamide IV once every 3 weeks.
Patients receive a maximum of 6 courses of treatment in the absence of disease progression
and unacceptable toxicity. Patients then undergo surgery (if operable) followed by more
chemotherapy (if node positive), radiation therapy, and oral tamoxifen for 5 years (at the
discretion of the investigator for estrogen receptor-negative patients). Patients are
followed at 12, 18, and 24 months, and then annually for at least 5 years.
PROJECTED ACCRUAL: A total of 350 patients (175 per arm) will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven previously untreated locally advanced or
inflammatory breast cancer Potentially operable disease Tumor at least 3 cm in diameter No
metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 to 60 Sex: Female Menopausal status: Not specified
Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute
neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin
greater than 9 g/dL Hepatic: PT and aPTT normal Bilirubin normal (except in patients with
benign congenital hyperbilirubinemia) AST/ALT no greater than 1.5 times upper limit of
normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN No active hepatitis B or C
Liver biopsy normal (if positive serology for hepatitis B or C) Renal: Creatinine normal
Cardiovascular: Adequate cardiac function No active cardiac disease Other: Not pregnant
Fertile patients must use effective contraception No other serious medical or psychiatric
disease No prior or concurrent malignancy except basal cell skin cancer or carcinoma in
situ of the cervix HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease
Characteristics Other: No prior therapy for breast cancer
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
T.R.J. Evans
Investigator Role:
Study Chair
Investigator Affiliation:
Beatson Institute for Cancer Research - Glasgow
Authority:
United States: Federal Government
Study ID:
CDR0000066780
NCT ID:
NCT00003679
Start Date:
November 1998
Completion Date:
Related Keywords:
- Breast Cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- inflammatory breast cancer
- Breast Neoplasms
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