A Study of Gemcitabine, Epirubicin, and Paclitaxel Combination Chemotherapy Given Before Surgery to Patients With Locally Advanced Breast Cancer

Phase 2

Completed

• Conditions: Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IV Breast Cancer; Breast Cancer; Locally Advanced

• Registration Number: NCT00378313
• Lead Sponsor: NSABP Foundation Inc

Brief Summary

The primary purpose of this study is to determine whether locally advanced breast cancer responds (by shrinking, by not progressing or by being destroyed) to combined chemotherapy (gemcitabine, epirubicin and paclitaxel) given before surgery to patients with locally advanced breast cancer. This study will also evaluate the toxicity of the chemotherapy combination to patients and will determine survival and progression-free survival 2 years after treatment. Also, the study will look at whether there are molecular and genetic changes in the tumor tissue that match the tumor's response to the chemotherapy.

Detailed Description

Primary chemotherapy has had an established role in locally advanced breast cancer. Studies have shown that the combination of chemotherapeutic agents is superior to single therapeutic agent in overall response rate and progression free survival. The inclusion of the most active drugs in combination regimens can improve the percentage of patients achieving a pathological complete response (pCR). The chemotherapy agents gemcitabine, epirubicin, and paclitaxel have been used individually to treat breast cancer. While use of the combination of these three drugs has been studied in the metastatic setting, the combination has not been evaluated in locally advanced disease. In this study the combination of the three agents gemcitabine, epirubicin, and paclitaxel \[Taxol\] will be administered to patients with locally advanced breast cancer prior to surgery; pathologic response will be determined at the time of surgery. The main objective of this study is to determine the pathological response rate for these patients. Also because prior studies have suggested that only a specific subset of tumors responds to a specific chemotherapeutic agent and that this subset is determined by the gene expression profile of each tumor, preoperative therapy protocols such as this provide an ideal setting to identify gene expression pattern and gene copy number changes that may predict response to a specific therapy using high-throughput assay methods and RNAlater. Therefore, this study will also look at the feasibility of tissue collection and analysis in identifying predictive markers of complete pathological response.

Study Timeline

• Study Start: 2001-11
• Study Completion: 2005-11
• Study First Submitted: 2006-09-07
• Study First Submitted QC: 2006-09-15
• Study First Posted: 2006-09-19
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-24
• Last Update Posted: 2008-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the pathological response rate in tumors of patients with locally advanced breast cancer who receive 4 to 6 cycles of GET chemotherapy

Secondary Outcome Measures

Name	Time	Method
To determine the clinical response rate
to evaluate the toxicity of the GET combination
to determine feasibility of tissue collection and analysis of potential molecular and genetic correlates of response; to determine the 2-year survival and 2-year progression-free survival

Trial Locations

Locations (1)

NSABP Foundation, Inc.; 🇺🇸 Pittsburgh, Pennsylvania, United States