drugset / Trial / NCT00296010

Liposomal Doxorubicin Compared With Observation or Cyclophosphamide and Methotrexate in Treating Older Women Who Have Undergone Surgery for Breast Cancer

NCT00296010 ↗

Phase 3 Terminated 77 enrolled ETOP IBCSG Partners Foundation
RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, and liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving liposomal doxorubicin after surgery is more effective than observation or cyclophosphamide and methotrexate in treating breast cancer. PURPOSE: This randomized phase III trial is studying liposomal doxorubicin to see how well it works compared with observation or cyclophosphamide and methotrexate in treating older women who have undergone surgery for breast cancer.

Timeline

Start
2005-08
Primary completion
2011-12
Completion
2011-12

Outcome

Outcome not reported

Stopped (Enrollment): “Accrual rate was too low”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified 50 mg Oral
Subject Doxorubicin Other / unclassified 20 mg/m2 Intravenous
Comparator Methotrexate Small molecule 2.5 mg Oral

Indications