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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Adjuvant Bevacizumab and Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Patients With Resected Lymph Node-Positive Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	ECOG-E2104 E2104, NCT00119262, NCCTG-E2104

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Has undergone surgery to remove the tumor within the past 4-12 weeks
• No inflammatory breast cancer
• No previous chemotherapy, hormone therapy, or radiation therapy for this cancer
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be assigned to one of two treatment groups.

Patients in group one will receive an infusion of doxorubicin, an infusion of cyclophosphamide, and a 30- to 90-minute infusion of bevacizumab in week 1. They will also receive an injection of G-CSF once a day for 6 days in week 1 and for 4 days in week 2 or an injection of pegfilgrastim once in week 1. Treatment may repeat every 2 weeks for up to four courses. Patients will then receive a 3-hour infusion of paclitaxel and a 30- to 90-minute infusion of bevacizumab in week 1. They will also receive G-CSF or pegfilgrastim as above. Treatment with paclitaxel, bevacizumab, and G-CSF or pegfilgrastim may repeat every 2 weeks for up to four courses. Patients will then receive bevacizumab alone every 2 weeks for up to 18 courses.

Patients in group two will receive doxorubicin, cyclophosphamide, and G-CSF or pegfilgrastim as in group one. They will then receive paclitaxel, bevacizumab, and G-CSF or pegfilgrastim as in group one. Patients will then receive bevacizumab alone every 2 weeks for up to 22 courses.

Beginning no more than 6 weeks later, some patients may undergo radiation therapy. Some patients may also receive hormone therapy by mouth once a day for up to 5 or 10 years.

Patients will be evaluated every 3 months for 6 months and every 6 months for up to 3 years from study entry.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Kathy Miller, MD, Protocol chair		Ph: 317-274-1690; 888-600-4822 Email: kathmill@iupui.edu
Robin Zon, MD, Protocol co-chair		Ph: 574-234-5123

North Central Cancer Treatment Group

Edith Perez, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
Official Title		Phase II Feasibility Trial Incorporating Bevacizumab into Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Patients with Lymph Node Positive Breast Cancer
Trial Start Date		2005-10-06
Registered in ClinicalTrials.gov		NCT00119262
Date Submitted to PDQ		2005-05-20
Information Last Verified		2006-11-27
NCI Grant/Contract Number		CA21115

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