drugset / Trial / NCT00301925

Combination Chemotherapy in Treating Patients With Early Stage Breast Cancer That Has Been Removed By Surgery

NCT00301925

Phase 3 Unknown 4400 enrolled Institute of Cancer Research, United Kingdom
RandomizedFactorialTreatment

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early stage breast cancer that has been removed by surgery. PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens to compare how well they work in treating patients with early stage breast cancer that has been removed by surgery.

Timeline

Start
2005-12-16
Primary completion
2024-09
Completion
2024-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1250 mg/m2 Oral
Subject Cyclophosphamide Other / unclassified 100 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Epirubicin Small molecule 100 mg/m2
Subject Methotrexate Small molecule 40 mg/m2 Intravenous
Subject Pegfilgrastim Protein / enzyme biologic 6 mg
Subject fluorouracil Small molecule 600 mg/m2 Intravenous

Indications