drugset / Trial / NCT00003893

Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer

NCT00003893 ↗

Phase 3 Completed 2250 enrolled University Hospital Birmingham
RandomizedTreatment

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumors cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy is more effective for early-stage breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of adjuvant chemotherapy plus radiation therapy in treating women who have early-stage breast cancer.

Timeline

Start
1998-07
Primary completion
—
Completion
2006-04

Outcome

Met primary endpoint

paper With 10.2 years median follow-up, the ten-year local recurrence rates were 4.6% and 7.1% in the synchronous and sequential arms respectively (hazard ratio (HR) 0.62; 95% confidence interval (CI): 0.43-0.90; p = 0.012). PMID 31785830 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified — —
Subject Doxorubicin Other / unclassified — —
Subject Epirubicin Small molecule — —
Subject Methotrexate Small molecule — —
Subject Mitomycin C Other / unclassified — —
Subject Mitoxantrone Small molecule — —
Subject fluorouracil Small molecule — —