NCT00777673

Preoperative Chemotherapy in Triple Negative Invasive Breast Cancer That Can be Removed by Surgery.

Neoadjuvant Weekly Nab-paclitaxel (Abraxane®) Plus Carboplatin Followed By Doxorubicin Plus Cyclophosphamide With Bevacizumab Added Concurrently To Chemotherapy For Palpable And Operable Triple Negative Invasive Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Tennessee Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine how well this combination of chemotherapy drugs works with bevacizumab in eliminating primary tumor in the breast prior to surgery(pathological complete response or pCR in the breast). Bevacizumab is a drug that works by blocking new blood vessel formation by the tumor cells. Giving chemotherapy and bevacizumab before surgery may allow for lesser amount of breast tissue to be removed. To be able to predict in the future which patients are more likely to get pCR to this drug combination, specialized tests on tumor tissue will be performed.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab, nab-paclitaxel, carboplatin, doxorubicin hydrochloride, cyclophosphamide, PEG-Filgrastim	Eligible patients will receive: * nab-paclitaxel IV on days 1, 8, and 15. Treatment will be repeated every 28 days 28 days for 4 courses. * Carboplatin IV on day 1. Treatment will be repeated every 28 days for 4 courses. * Bevacizumab IV on days 1 and 15. Treatment will be repeated every 28 days for 4 courses. After completion of the above regimen, patients will receive: * Doxorubicin IV on day 1. Treatment will be repeated every 14 days for 4 courses. * Cyclophosphamide IV on day 1. Treatment will be repeated every 14 days for 4 courses. * Bevacizumab IV on day 1. Treatment will be repeated every 14 days for 2 courses. Patients will then proceed with: \- Surgery including axillary staging A minimum of 4 weeks post operatively, patient will receive: \- Bevacizumab IV on days 1 and 15. Treatment will be repeated every 28 days for 8 courses.

Timeline

• Start date: 2008-10-01
• Primary completion: 2013-01-01
• Completion: 2013-10-01
• First posted: 2008-10-22
• Last updated: 2013-01-04

Locations

3 sites across 1 country: United States