NCT00119262

Bevacizumab and Combination Chemotherapy in Patients With Lymph Node Positive Breast Cancer

Phase II Feasibility Trial Incorporating Bevacizumab Into Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Patients With Lymph Node Positive Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works in treating patients who have undergone surgery for breast cancer that has spread to the lymph nodes. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with more than one chemotherapy drug (combination chemotherapy), may be a better way to block tumor growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the incidence of clinically apparent cardiac dysfunction in patients with lymph node positive breast cancer treated with bevacizumab and dose dense doxorubicin/cyclophosphamide followed by paclitaxel (ddAC \> T). SECONDARY OBJECTIVES: I. To evaluate changes in LVEF during treatment. II. To evaluate non-cardiac toxicity. OUTLINE: This is a non-randomized, multicenter study. Patients are sequentially assigned to 1 of 2 treatment arms. Arm A: Patients receive doxorubicin IV, cyclophosphamide IV over 20-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SQ) on days 2-11 or pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients then receive paclitaxel IV over 3 hours and bevacizumab IV over 30-90 minutes on day 1. Patients also receive G-CSF or pegfilgrastim as above. Treatment with paclitaxel, bevacizumab, and G-CSF or pegfilgrastim repeats every 14 days for 4 courses. Patients then receive bevacizumab alone every 14 days for up to 18 courses. Arm B: Patients receive doxorubicin, cyclophosphamide, and G-CSF or pegfilgrastim as in group I. Patients then receive paclitaxel, bevacizumab, and G-CSF or pegfilgrastim as in group I. Patients then receive bevacizumab alone every 14 days for up to 22 courses. Treatment in both groups continues in the absence of disease recurrence or unacceptable toxicity. Patients who require radiotherapy (post-lumpectomy) or who plan radiotherapy at the discretion of the investigator (post-mastectomy) undergo radiotherapy beginning within 6 weeks after the completion of chemotherapy. Premenopausal patients with estrogen receptor (ER) and/or progesterone receptor (PR) positive disease receive oral tamoxifen once daily for 5 years beginning at the time of radiotherapy or within 6 weeks after the completion of chemotherapy. Postmenopausal patients with ER and/or PR positive disease receive an aromatase inhibitor (e.g., anastrozole, letrozole, or exemestane) or tamoxifen followed by an aromatase inhibitor once daily for up to 10 years. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for up to 3 years from study entry. ACCRUAL: A total of 226 patients (104 on arm A and 122 on arm B) were accrued for this study.

Conditions

• Male Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer

Interventions

Type	Name	Description
DRUG	doxorubicin hydrochloride	Given IV
DRUG	cyclophosphamide	Given IV
BIOLOGICAL	bevacizumab	Given IV
DRUG	paclitaxel	Given IV
BIOLOGICAL	filgrastim	Given SC
BIOLOGICAL	pegfilgrastim	Given SC
RADIATION	radiation therapy	Undergo radiation therapy
DRUG	tamoxifen citrate	Given orally
DRUG	aromatase inhibition therapy	Receive aromatase inhibition therapy

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-08-01
• Completion: 2009-09-01
• First posted: 2005-07-13
• Last updated: 2014-05-15
• Results posted: 2011-04-28

Locations

1 site across 1 country: United States