A Phase II Clinical Trial of Bevacizumab Beginning Concurrently With a Sequential Regimen of Doxorubicin and Cyclophosphamide Followed by Docetaxel and Capecitabine as Neoadjuvant Therapy Followed by Postoperative Bevacizumab Alone for Women With Locally Advanced Breast Cancer

NCT00365417 Phase 2 COMPLETED Results posted

Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy drugs kill cancer cells more directly. This study will evaluate: * How bevacizumab, given with chemotherapy before surgery, and then bevacizumab given alone after surgery, will affect locally advanced breast tumors * Side effects from adding bevacizumab to chemotherapy * Whether adding bevacizumab to chemotherapy for breast cancer will affect the heart * If receiving bevacizumab will have any effect on how patients recover from surgery * Side effects of the combinations of drugs used in this study

Details

Lead sponsor	NSABP Foundation Inc
Phase	Phase 2
Status	COMPLETED
Enrolment	45
Start date	2006-08
Completion	2009-11

Conditions

• Breast Cancer

Interventions

• Bevacizumab
• Doxorubicin
• Cyclophosphamide
• Capecitabine
• Docetaxel

Primary outcomes

• Pathologic Complete Response (pCR) in the Breast — Approximately 7 months
  Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen

Countries

United States