Combination Chemotherapy in Treating Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      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 and giving them after surgery may kill
      any remaining tumor cells following surgery. It is not yet known which combination
      chemotherapy regimen is more effective in treating breast cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination
      chemotherapy regimens in treating women who have primary breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the time to progression of women with primary breast cancer treated with
           fluorouracil, epirubicin, and cyclophosphamide vs docetaxel, epirubicin, and
           cyclophosphamide.

        -  Compare the overall survival of patients treated with these regimens.

        -  Compare the toxicity of these regimens in these patients.

        -  Compare quality of life of patients treated with these regimens.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
      according to metastatic axillary lymph node involvement (4-9 vs 10 or more), hormone receptor
      status (estrogen and/or progesterone) of the primary tumor (negative vs positive), and timing
      of adjuvant radiotherapy (intermittently after completion of 50% of chemotherapy vs after
      completion of all chemotherapy). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive fluorouracil IV over 10-15 minutes and epirubicin IV over 15
           minutes on days 1 and 8 and oral cyclophosphamide on days 1-14. Treatment repeats every
           4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

        -  Arm II: Patients receive epirubicin IV over 15 minutes and cyclophosphamide IV over 1
           hour on days 1, 21, 42, and 63 and docetaxel IV over 1 hour on days 84, 105, 126, and
           147 in the absence of disease progression or unacceptable toxicity.

      Within 21 days after the completion of chemotherapy, patients undergo adjuvant radiotherapy 5
      days a week for 5.5 weeks. Alternatively, patients may undergo radiotherapy intermittently
      after completion of 50% of chemotherapy.

      Upon completion of chemotherapy, patients with positive hormone receptor status (estrogen
      and/or progesterone) receive oral tamoxifen daily for 5 years. Additionally, patients with
      positive hormone receptor status who are under age 40 receive goserelin subcutaneously every
      4 weeks for 2 years.

      Quality of life is assessed at baseline, prior to each course of chemotherapy, 4 weeks after
      completion of chemotherapy, 6 weeks after completion of radiotherapy, and then at 6 months
      after completion of chemotherapy.

      Patients are followed every 3 months for 3 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 446 patients (223 per treatment arm) will be accrued for this
      study within 3 years.
    

Intervention name(s): cyclophosphamide; docetaxel; epirubicin hydrochloride; fluorouracil; goserelin acetate; tamoxifen citrate; adjuvant therapy; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Tamoxifen; Cyclophosphamide; Docetaxel; Fluorouracil; Epirubicin; Goserelin
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer