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

Alternate Title

Phase III Randomized Study of Adjuvant Therapy Comprising Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With Versus Without Bevacizumab in Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer

Basic Trial Information

Special Category: CTSU trial

Trial Description

Purpose:

Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 breast cancer by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether doxorubicin, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab in treating breast cancer.

This randomized phase III trial is studying doxorubicin, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with lymph node-positive or high-risk, lymph node-negative breast cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Has undergone surgery (total mastectomy or lumpectomy) with either axillary dissection or sentinel node biopsy within the past 4-12 weeks
• No HER2/neu positive breast cancer or inflammatory breast cancer
• More than 4 weeks since surgery
• No previous chemotherapy or hormone therapy (other than tamoxifen or raloxifene for breast cancer prevention) 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 randomly assigned (have an chance of being placed) to one of three treatment groups.

Patients in group one will receive infusions of doxorubicin and cyclophosphamide and a 30- to 90-minute infusion of a placebo once in week 1. Treatment may repeat every 2 or 3 weeks for up to four courses. Beginning 3 weeks later, patients will then receive a 1-hour infusion of paclitaxel once in weeks 1-3 and a 30- to 90-minute infusion of a placebo once in week 1. Treatment with paclitaxel and placebo may repeat every 3 weeks for up to four courses.

Patients in group two will receive infusions of doxorubicin and cyclophosphamide and a 30- to 90-minute infusion of bevacizumab once in week 1. Treatment may repeat every 2 or 3 weeks for up to four courses. Beginning 3 weeks later, patients will then receive a 1-hour infusion of paclitaxel once in weeks 1-3 and a 30- to 90-minute infusion of bevacizumab once in week 1. Treatment with paclitaxel and bevacizumab may repeat every 3 weeks for up to four courses.

Patients in group three will receive infusions of doxorubicin and cyclophosphamide and a 30- to 90-minute infusion of bevacizumab once in week 1. Treatment may repeat every 2 or 3 weeks for up to four courses. Beginning 3 weeks later, patients will then receive a 1-hour infusion of paclitaxel once in weeks 1-3 and a 30- to 90-minute infusion of a bevacizumab once in week 1. Treatment with paclitaxel and bevacizumab may repeat every 3 weeks for up to four courses. Beginning 2 months later, patients will then receive a 30- to 90-minute infusion of bevacizumab every 3 weeks for up to 10 courses.

Patients will complete quality of life questionnaires and receive telephone quality of life interviews periodically. After finishing treatment, patients will be evaluated periodically for up to 15 years.(QOL closed as of 05/28/10)

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
Ramona Swaby, MD, Protocol co-chair		Ph: 215-728-0417; 888-369-2427

North Central Cancer Treatment Group

Donald Northfelt, MD, FACP, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Cancer and Leukemia Group B

Chau Dang, MD, Protocol co-chair		Ph: 212-639-5426; 800-525-2225

Related Information

PDQ® clinical trial NCI-2009-00707

Registry Information
Official Title		A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
Trial Start Date		2007-11-02
Trial Completion Date		2016-09-30 (estimated)
Registered in ClinicalTrials.gov		NCT00433511
Date Submitted to PDQ		2006-12-27
Information Last Verified		2011-02-28
NCI Grant/Contract Number		CA21115

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