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.
Allocation: Randomized, Primary Purpose: Treatment
Beatson Institute for Cancer Research - Glasgow
United States: Federal Government