drugset / Trial / NCT00378313

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

NCT00378313 ↗

Phase 2 Completed 76 enrolled NSABP Foundation Inc
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2001-11
Primary completion
—
Completion
2005-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Epirubicin Small molecule 90 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous