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A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:
A Phase II Randomized Study of Pegylated Liposomal Doxorubicin, Cyclophosphamide Versus Epirubicin-Cyclophosphamide as Adjuvant Chemotherapy in Her2-negative Stage I and II Breast Cancer Patients

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01210768
Study type Interventional
Source TTY Biopharm
Contact
Status Recruiting
Phase Phase 2
Start date June 2010
Completion date August 2018
View Details
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