Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
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. It is not yet known which regimen of chemotherapy is more effective
      for breast cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of
      combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that
      has spread to the lymph nodes.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the disease-free survival and overall survival in patients with node-positive or
           high-risk node-negative operable stage II or IIIA breast cancer treated with docetaxel
           or paclitaxel after doxorubicin and cyclophosphamide.

        -  Determine whether the weekly administration of paclitaxel or docetaxel for 12 weeks
           improves disease-free survival and overall survival when compared with the conventional
           schedule of every 3 weeks for 4 courses after doxorubicin and cyclophosphamide in this
           patient population.

        -  Compare the toxic effects of docetaxel and paclitaxel when administered weekly for 12
           weeks versus every 3 weeks for 4 courses in these patients.

        -  Compare the toxicity of paclitaxel administered every 3 weeks for 4 courses or weekly
           for 12 weeks to that of docetaxel administered on the same schedules in these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      estrogen receptor status (positive vs negative vs unknown), nodal status (0 positive nodes vs
      1-3 positive nodes vs 4-9 positive nodes vs at least 10 positive nodes), tumor size (no more
      than 5 cm vs more than 5 cm vs unknown), and type of prior surgery (mastectomy vs breast
      conservation surgery). Patients are randomized to one of four treatment arms.

        -  Arm I: Patients receive doxorubicin IV and cyclophosphamide IV every 3 weeks for 4
           courses (weeks 1-12). Beginning at week 13, patients receive paclitaxel IV over 3 hours
           every 3 weeks for 4 courses.

        -  Arm II: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at week
           13, patients receive paclitaxel IV over 1 hour weekly for 12 weeks.

        -  Arm III: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at
           week 13, patients receive docetaxel IV over 1 hour every 3 weeks for 4 courses.

        -  Arm IV: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at week
           13, patients receive docetaxel IV over 1 hour weekly for 12 weeks.

      Within 4 weeks after completion of chemotherapy, patients with estrogen and/or progesterone
      receptor positive tumors receive oral tamoxifen daily for 5 years.

      After completion of all chemotherapy, patients with prior segmental mastectomy receive
      radiotherapy once daily 5 days per week for 5-6 weeks. Patients with prior modified radical
      mastectomy may receive radiotherapy after chemotherapy completion at the investigator's
      discretion.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study within 1.27
      years.
    

Intervention name(s): cyclophosphamide; docetaxel; doxorubicin hydrochloride; paclitaxel; tamoxifen citrate; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Radiation
Intervention MeSH terms: Tamoxifen; Paclitaxel; Docetaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage II breast cancer; stage IIIA breast cancer