Spots Global Cancer Trial Database for A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients

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Trial Identification

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

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

Study ID: NCT01210768

Conditions

Breast Cancer

Interventions

Epirubicin+Cyclophosphamide

liposomal-doxorubicin+Cyclophosphamide

Study Description

Brief 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.

Detailed Description: