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Phase II Trial of Caelyx and Cyclophosphamide in Metastatic Breast Cancer
Women with metastatic breast cancer are usually treated with anthracyclines (ie, doxorubicin or epirubicin) but cardiac toxicity limits their use. The aim of this study is to evaluate the safety and efficacy of Caelyx in combination with cyclophosphamide in women with metastatic breast cancer who have received adjuvant anthracyclines with or without a taxane.
Details
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 70 |
| Start date | 2003-03 |
| Completion | 2007-08 |
Conditions
- Breast Neoplasm
Interventions
- Pegylated Lyposomal Doxorubicin
- Cyclophosphamide
Primary outcomes
- Time to response; Duration of response; Time to progression; Survival — With complete or partial response, subjects will be re-evaluated 4 weeks later to confirm the initial observation; Follow-up for a minimum of one year for survival.