A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to learn if adding bevacizumab to standard treatment with
      chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative
      breast cancer will prevent breast cancer from returning. A second purpose of this study is to
      learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative
      breast cancer live longer. The researchers also want to learn about the side effects of the
      combination of drugs used in this study.
    

Detailed description: 
      The B-46-I/07132 study, a multicenter, open-label, randomized Phase III, adjuvant therapy
      trial, will compare the value of adding bevacizumab to a non-anthracycline-based chemotherapy
      regimen relative to the same chemotherapy without bevacizumab and relative to an
      anthracycline-based chemotherapy regimen in women with resected node-positive or high-risk
      node-negative, HER2-negative breast cancer. This trial will determine whether the addition of
      bevacizumab to a regimen of docetaxel and cyclophosphamide (TCB) improves invasive
      disease-free survival relative to docetaxel and cyclophosphamide alone (TC). A secondary aim
      will be to determine whether the addition of bevacizumab to TC improves invasive disease-free
      survival compared to a regimen of docetaxel, doxorubicin, and cyclophosphamide (TAC). Other
      secondary aims include whether TCB improves disease-free survival, overall survival, and
      recurrence-free interval relative to TC alone and to TAC. The toxicities of the three
      regimens will also be compared.

      Patients in the B-46-I/07132 study will be randomized to one of three treatment regimens:
      Group 1 patients will receive 6 cycles of TAC administered every 21 days (docetaxel 75 mg/m2,
      doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2); Group 2 patients will receive 6 cycles
      of TC administered every 21 days (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2); and Group
      3 patients will receive 6 cycles of TCB every 21 days with bevacizumab therapy continuing
      every 21 days after completion of chemotherapy until 1 year following the first dose
      (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2, and bevacizumab 15 mg/kg). Primary
      prophylaxis with pegfilgrastim or filgrastim is required for Group 1 patients (optional for
      patients in Groups 2 and 3). Patients will also receive adjuvant radiation therapy as
      clinically indicated and endocrine therapy for hormone receptor-positive tumors.

      Tumor samples will be submitted for correlative science studies to evaluate predictors of
      study therapy benefit. Submission of a tumor sample is a study requirement for all patients.
    

Intervention name(s): bevacizumab; docetaxel; doxorubicin; cyclophosphamide; pegfilgrastim
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): bevacizumab 15 mg/kg IV every 21 days for 6 cycles followed by bevacizumab 15 mg/kg IV every 21 days until 1 year following the first dose of bevacizumab; docetaxel 75 mg/m2 IV every 21 days for 6 cycles; doxorubicin 50 mg/m2 IV every 21 days for 6 cycles; Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and 3: cyclophosphamide 600 mg/m2 IV every 21 days for 6 cycles; pegfilgrastim 6 mg subcutaneous (SC) Day 2 every 21 days for 6 cycles [filgrastim (Neupogen®) 5 mcg/kg Days 2-10 may be given in lieu of pegfilgrastim (Neulasta®), but pegfilgrastim is preferred.]
Other intervention name(s): T; A; C
Intervention MeSH terms: Cyclophosphamide; Bevacizumab; Docetaxel; Doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: National Surgical Adjuvant Breast and Bowel Project (NSABP); Taxotere; Docetaxel; Doxorubicin; Cyclophosphamide; Bevacizumab; Breast Neoplasms; Adenocarcinoma; Breast Diseases; Carcinoma; HER2 negative; Node negative; High risk node positive; Adjuvant Therapy