Multicenter phase III randomized trial of adjuvant therapy for patients with HER2-positive node-positive or high risk node-negative breast cancer comparing chemotherapy plus trastuzumab with chemotherapy plus trastuzumab plus bevacizumab

eagle-i ID

Resource Type

Properties

1. ClinicalTrials.gov url

   http://www.clinicaltrials.gov/ct2/show/NCT00625898

2. Intervention

   Docetaxel

3. Intervention

   Trastuzumab

4. Intervention

   Carboplatin

5. Intervention

   Bevacizumab

6. Intervention

   5-Fluorouracil

7. Intervention

   Epirubicin

8. Intervention

   Cyclophosphamide

9. Resource Description

   "This Phase III, randomized, open-label trial will determine whether the regimens of chemotherapy plus trastuzumab plus bevacizumab improve invasive disease-free survival (IDFS) relative to the regimens of chemotherapy plus trastuzumab. Secondary aims include determining whether the addition of bevacizumab to chemotherapy plus trastuzumab will improve disease-free survival (DFS), overall survival (OS), recurrence-free interval (RFI), and distant recurrence-free interval (DRFI). The benefit of adding bevacizumab for IDFS, DFS, OS, RFI, and DRFI will also be evaluated for each of the two chemotherapy regimens. The cardiac and non-cardiac toxicities of each of the regimens will also be evaluated."

10. Additional Name

    BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab

11. Contact

    Berenberg, Jeffrey

12. PI

    Berenberg, Jeffrey

13. Topic

    breast cancer

14. Study Population

    At least 3,500 women aged 18 years and older with a life expectancy of at least 10 years, excluding their diagnosis of breast cancer, who also meet all other criteria listed on clinicaltrials.gov.

15. Funded by

    National Surgical Adjuvant Breast and Bowel Project

16. Phase

    Phase 3 clinical trial

17. Performed by

    Clinical Protocol & Data Management Shared Resource