drugset / Trial / NCT00066443

Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer

NCT00066443

Phase 1/2 Completed 93 enrolled NCIC Clinical Trials Group
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy such as epirubicin and docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin and docetaxel with pegfilgrastim in treating women who have locally advanced or inflammatory breast cancer.

Timeline

Start
2003-11-03
Primary completion
2010-01-06
Completion
2014-01-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 50 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Docetaxel Small molecule 85 mg/m2 Intravenous
Subject Epirubicin Small molecule 50 mg/m2 Intravenous
Subject Epirubicin Small molecule 75 mg/m2 Intravenous
Subject Epirubicin Small molecule 90 mg/m2 Intravenous
Subject Epirubicin Small molecule 120 mg/m2 Intravenous
Background Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous

Indications