Study on Chemotherapy and Bevacizumab for Treating Breast Cancer with Lymph Node Involvement or High Risk of Return
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT00433511
This clinical trial is testing whether adding the drug bevacizumab to standard chemotherapy can improve treatment outcomes for patients with breast cancer that has spread to the lymph nodes or is at high risk of returning.
Patient Parameters
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Program Overview
The purpose of this study is to determine if adding bevacizumab to the standard chemotherapy drugs doxorubicin, cyclophosphamide, and paclitaxel can help control breast cancer that has spread to the lymph nodes or is at high risk of coming back. Chemotherapy works by killing cancer cells or stopping them from growing and spreading. Bevacizumab is a monoclonal antibody that may help stop cancer growth by blocking blood flow to the tumor. The study will compare the effectiveness of chemotherapy with and without bevacizumab.
Description
The study has several goals:
- To see if adding bevacizumab to chemotherapy improves disease-free survival, meaning the cancer does not return.
- To compare short-term versus long-term use of bevacizumab.
- To evaluate overall survival rates and any side effects.
- To assess the quality of life of patients receiving the treatments.
- To explore how genetic factors might influence treatment outcomes.
- To collect samples for future research on cancer recurrence and patient health.
Participants will be randomly assigned to one of three groups:
- Group 1: Receives standard chemotherapy with doxorubicin, cyclophosphamide, and paclitaxel, along with a placebo.
- Group 2: Receives the same chemotherapy drugs plus bevacizumab.
- Group 3: Receives the same chemotherapy drugs plus bevacizumab, followed by additional bevacizumab treatment.
All treatments will continue unless the cancer progresses or side effects become too severe. After completing the study treatment, participants will be monitored for 15 years.
Eligibility Criteria
Inclusion Criteria
- Must have breast cancer that is at high risk of spreading or returning, based on specific medical criteria.
- Must have completed surgery to remove the breast cancer, such as mastectomy or lumpectomy.
- Must start treatment between 28 and 84 days after surgery.
- Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have adequate blood cell counts and organ function based on recent tests.
- Must agree to receive radiation therapy if they had breast-conserving surgery.
- Must not have HER2-positive breast cancer.
- Must not have received prior chemotherapy or hormonal therapy for this breast cancer.
- Must not have significant heart or blood vessel problems.
- Must not be pregnant or breastfeeding and must agree to use effective contraception if of childbearing potential.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northeast Alabama Regional Medical Center | 36202 | Anniston | Alabama |
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Providence Hospital | 36608 | Mobile | Alabama |
| Alaska Regional Hospital | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Virginia G Piper Cancer Care-Del Camino | 85258 | Scottsdale | Arizona |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| Mercy Hospital Fort Smith | 72903 | Fort Smith | Arkansas |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Kaiser Permanente-Deer Valley Medical Center | 94531 | Antioch | California |
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