NCT00530868

Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer

A Phase II, Randomized, Open Label Trial of Pre-operative (Neoadjuvant)Letrozole (Femara) vs. Letrozole in Combination With Avastin in Post Menopausal Women With Newly Diagnosed Operable Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This purpose of this trial is to show that the combination of Avastin and hormone therapy should be more effective than hormone therapy alone for the treatment of breast cancer.

Detailed description

Preclinical and clinical data have demonstrated that up-regulation of tumor cell VEGF is an important mechanism to subvert estrogen dependence in hormone responsive breast cancer resulting in reduced therapy response or tumor resistance to hormonal therapy; thus, it is hypothesized that the combination of an anti-VEGF agent (Avastin, an anti-VEGF monoclonal antibody) and hormonal therapy should be more effective than hormonal therapy alone for the treatment of breast cancer.

Conditions

• Breast Cancer
• Cancer of the Breast
• Breast Neoplasm

Interventions

Type	Name	Description
OTHER	Letrozole (Femara)	Letrozole 2.5 mg PO a day for 24 weeks
DRUG	Letrozole; Avastin	Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks

Timeline

• Start date: 2007-10-08
• Primary completion: 2022-03-01
• Completion: 2022-03-31
• First posted: 2007-09-18
• Last updated: 2022-10-21
• Results posted: 2022-10-21

Locations

7 sites across 1 country: United States