NCT00365417

Therapy With Bevacizumab (BEV), Doxorubicin, and Cyclophosphamide Followed by BEV, Docetaxel, and Capecitabine Before Surgery Followed by BEV Alone After Surgery for Women With Locally Advanced Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: NSABP Foundation Inc · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Initial trials of neoadjuvant chemotherapy administered for locally advanced tumors, including those in breast cancer, demonstrated therapy could induce sufficient tumor regression to allow for the resection of otherwise unresectable tumors. Subsequent demonstration of the equivalence of lumpectomy to mastectomy in patients with operable breast cancer, stimulated interest in the concept of using preoperative chemotherapy to reduce large, but operable, primary tumors to allow for lumpectomy in women who would otherwise require a mastectomy. Given the data from previous studies, it is appropriate to continue development of sequential doxorubicin/cyclophosphamide/docetaxel regimens to improve on clinical and pathologic response rates. FB-4 is a Phase II, single arm study for women with locally advanced human epidermal growth factor receptor 2 (HER2)-negative breast cancer diagnosed by core needle biopsy. The primary aim of the study is to determine the pathologic complete response rate in the breast following neoadjuvant chemotherapy combined with bevacizumab.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	15 mg/kg IV every 21 days x 4 cycles, then after clinical response assessment, 15 mg/kg IV every 21 days x 2 cycles, then following surgery, 15 mg/kg every 21 days x 10 cycles
DRUG	Doxorubicin	60 mg/m\^2 IV every 21 days x 4 cycles
DRUG	Cyclophosphamide	600 mg/m\^2 IV every 21 days x 4 cycles
DRUG	Capecitabine	Following clinical response assessment, 650 mg/m\^2 twice a day (orally), days 1-14 every 21 days x 4 cycles
DRUG	Docetaxel	Following clinical response assessment, 75 mg/m\^2 IV every 21 days x 4 cycles

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-02-01
• Completion: 2009-11-01
• First posted: 2006-08-17
• Last updated: 2021-04-13
• Results posted: 2010-08-12

Locations

1 site across 1 country: United States