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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 (NCT00003679)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether doxorubicin plus docetaxel is more effective than doxorubicin plus cyclophosphamide for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of doxorubicin in combination with either docetaxel or cyclophosphamide in treating women who have previously untreated, advanced, or inflammatory breast cancer.
  • Drug: cyclophosphamide
    • Drug: docetaxel
      • Drug: doxorubicin hydrochloride
        • Drug: tamoxifen citrate
          • Procedure: conventional surgery
            • Radiation: radiation therapy
              Ages eligible for Study
              18 Years to 60 Years
              Genders eligible for Study
              Female
              Accepts Healthy Volunteers
              No
              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.

              1 locations

              United Kingdom (1)
              • C.R.C. Beatson Laboratories
                Not specified
                Glasgow, Scotland, United Kingdom, G61 1BD
              Status:
              unknown
              Type:
              Interventional
              Phase:
              Start:
              31 October, 1998
              Updated:
              04 November, 2013
              Participants:
              350
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