drugset / Trial / NCT00194779

Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery

NCT00194779

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well giving combination chemotherapy and filgrastim together before surgery works in treating patients with human epidermal growth receptor 2 (HER2)-positive breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Colony-stimulating factors, such as filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving doxorubicin hydrochloride, cyclophosphamide, and filgrastim together followed by paclitaxel before surgery may be an effective treatment for breast cancer

Timeline

Start
2003-10
Primary completion
2010-06
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule Oral
Subject Cyclophosphamide Other / unclassified Oral
Subject Doxorubicin Other / unclassified Intravenous
Subject Letrozole Other / unclassified Oral
Subject Methotrexate Small molecule Intravenous
Subject Paclitaxel Small molecule Intravenous
Subject Tamoxifen Small molecule Oral
Subject Trastuzumab Monoclonal antibody Intravenous
Subject Vinorelbine Small molecule Intravenous
Background filgrastim Protein / enzyme biologic Subcutaneous