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Phase III 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

eagle-i ID


Resource Type

  1. Clinical trial


  1. ClinicalTrials.gov url
  2. Intervention
  3. Intervention
    Docetaxel/cyclophoasphamide/bevacizumab (TCB)
  4. Intervention
    Docetaxel/cyclophosphamide (TC)
  5. Intervention
    Docetaxel/doxorubicin/cyclophosphamide (TAC)
  6. Additional Topic(s)
    Combined antineoplastic chemotherapy
  7. Resource 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.
  8. Contact
    Berenberg, Jeffrey
  9. PI
    Berenberg, Jeffrey
  10. Topic
    breast cancer
  11. Study Population
    Women 18 to 70 years old with unilateral, HER2- negative invasive adenocarcinoma of the breast who have undergone either a total mastectomy or breast-conserving surgery (lumpectomy), and whose tumor meet specific staging criteria.
  12. Funded by
    National Surgical Adjuvant Breast and Bowel Project
  13. Phase
    Phase 3 clinical trial
  14. Performed by
    Clinical Protocol & Data Management Shared Resource
Provenance Metadata About This Resource Record
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