drugset / Trial / NCT00002755

Standard Chemotherapy Compared With High-Dose Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer

NCT00002755

Phase 3 Completed 600 enrolled Scottish Cancer Therapy Network
RandomizedTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of standard cyclophosphamide, methotrexate, and fluorouracil with that of high-dose combination chemotherapy plus peripheral stem cell transplantation in treating women who have stage II or stage IIIA breast cancer.

Timeline

Start
1995-11
Primary completion
Completion
1999-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified Intravenous
Subject Methotrexate Small molecule
Subject Thiotepa Other / unclassified Intravenous
Subject fluorouracil Small molecule Intravenous
Background Doxorubicin Other / unclassified Intravenous
Background Tamoxifen Small molecule Oral
Background filgrastim Protein / enzyme biologic Subcutaneous

Indications