NCT00110695

Therapy With Abraxane and 5-Fluorouracil, Epirubicin, Cyclophosphamide (FEC) for Patients With Breast Cancer

A Phase 2 Study of Neoadjuvant Chemotherapy With Sequential Weekly Nanoparticle Albumin Bound Paclitaxel (Abraxane) Followed by 5-Fluorouracil, Epirubicin, Cyclophosphamide (FEC) in Locally Advanced Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: NSABP Foundation Inc · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn how breast cancer tumors respond to a drug called Abraxane followed by a combination of 3 chemotherapy drugs commonly used for breast cancer.

Detailed description

This is a Phase 2, non-randomized study of neoadjuvant treatment with nanoparticle albumin bound paclitaxel (Abraxane) every week for 12 weeks followed by 5-FU, epirubicin, and cyclophosphamide (FEC) every 3 weeks for 4 cycles in women with locally advanced breast cancer. Patients with HER-2 overexpressing breast cancer may receive trastuzumab concurrently with the chemotherapy at the discretion of the investigator. The primary aim of this study is to determine the pathologic complete response rate (pCR) of this sequential regimen. Patients who achieve clinical complete response (cCR), clinical partial response (cPR), or have resectable stable disease (SD) will undergo surgery. Surgery will consist of modified radical mastectomy or excision of the primary tumor site with clear surgical margins accompanied by axillary staging. Tumor samples taken prior to initiation of treatment will be analyzed for molecular and genetic changes which will be correlated with tumor response. Patients must have a histologically confirmed diagnosis of breast cancer without documented evidence of distant metastatic disease. Patients with clinical Stage IIB (T3N0 only), IIIA, or IIIB breast cancer will be potential candidates for this trial.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Nanoparticle albumin bound paclitaxel followed by FEC	Nanoparticle albumin bound paclitaxel 100 mg/m2 IV for 30 minutes once weekly for 12 weeks followed by FEC (5-FU 500mg/m2 IV push; epirubicin 100 mg/m2 IV over 15 min. \[or if given with trastuzumab 75 mg/m2 IV over 15 min.\]; cyclophosphamide 500 mg/m2 IV over 30 min.) on Day 1 every 21 days

Timeline

• Start date: 2005-04-01
• Primary completion: 2006-12-01
• Completion: 2008-07-01
• First posted: 2005-05-13
• Last updated: 2010-03-26

Locations

1 site across 1 country: United States