Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer: A Pilot Study

Breast Cancer Clinical Trial

Official title: Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymp Node Positive Breast Cancer: A Pilot Study

Status Recruiting

Clinical Trial Summary

This research focuses on women with breast cancer whose disease has not significantly progressed, but who have 5 or more lymph nodes involved. In this study subjects will receive bevacizumab, a drug which is FDA approved for colon cancer but not for breast cancer, in combination with a regimen of approved chemotherapy drugs known as "dose dense chemotherapy." The study will observe the effectiveness and tolerability of this regimen.

Clinical Trial Description

Approximately 200,000 women are diagnosed with breast cancer in the United States every year. A significant factor determining long-term survivability of breast cancer is whether or not lymph nodes, glands which cleanse and filter the body's fluids, are involved. Despite treatment with approved multiagent cytotoxic chemotherapy ("dose-dense chemotherapy"), women with breast cancer involving more than 4 axillary lymph nodes still have a high risk for recurrence.

Several dose-dense chemotherapy regimens are currently being compared in other studies, however, at this time there is no proof that one regimen is superior to another. Therefore, in an attempt to decrease metastases, prolong time to recurrence and improve overall survival, it is essential to develop novel therapeutic strategies. The use of inhibitors of angiogenesis represents a promising option.

Bevacizumab is the first angiogenesis inhibiting drug to be FDA approved, for the treatment of colon cancer. It is has also been studied alone in progressed lymph-node positive breast cancer and has shown moderate efficacy.

This study will observe the efficacy and tolerability of using bevacizumab in combination with an approved dose-dense chemotherapy regimen for 8 cycles, followed by 12 of bevacizumab alone. Patients may be on the study for up to 52 weeks if their disease has not progressed and the regimen is tolerated. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00378638
• Study type: Interventional
• Source: Chap, Linnea I., M.D.
• Contact: Linnea I. Chap, MD
• Phone: (310) 633-8400
• Email: lchap@premiereoncology.com
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2006
• Completion date: October 2008