drugset / Trial / NCT01210768
A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary objective: * To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer Secondary objectives: * To assess the overall survival (OS) * To establish the safety profile by assessing the toxicities and tolerability * To assess the quality of life (QoL) * To evaluate survival correlation with biomarkers expression.
Timeline
- Start
- 2010-06
- Primary completion
- 2022-10-31
- Completion
- 2022-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 37.5 mg/m2 | — |
| Comparator | Epirubicin | Small molecule | 90 mg/m2 | — |