NCT00392392

Preoperative Bevacizumab and Trastuzumab With ABI-007 and Carboplatin in HER2+ Breast Cancer

Phase II Study of Preoperative Bevacizumab and Trastuzumab Administered With ABI-007 and Carboplatin in HER2 Overexpressing Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial combines trastuzumab and bevacizumab monoclonal antibodies, with ABI-007 and carboplatin, as neoadjuvant therapy in previously untreated locally advanced breast cancers demonstrating HER2 gene amplification. It is hoped that this novel combination will result in increased pathologic response rates that will translate into long term outcome improvements in HER2 positive patients with locally advanced breast cancer.

Detailed description

All eligible patients will receive induction chemotherapy prior to consideration of primary surgical intervention. If surgical intervention is deemed not to be in the best interest of the patient, patient will go off study at the time of evaluation for surgery. Upon completion of chemotherapy and surgery, all ER + and/or PR + patients will be placed on Tamoxifen 20 mg/qd or an aromatase inhibitor. Induction preoperative therapy: * Bevacizumab * Trastuzumab * ABI-007 * Carboplatin Postoperative Adjuvant Therapy: * Bevacizumab * Trastuzumab

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	nab-paclitaxel	ABI-007
DRUG	Bevacizumab	Bevacizumab
DRUG	Trastuzumab	Trastuzumab

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-04-01
• Completion: 2011-12-01
• First posted: 2006-10-26
• Last updated: 2013-09-20
• Results posted: 2013-02-13

Locations

6 sites across 1 country: United States