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Brief Title: DPPE in Combination With Epirubicin and Cyclophosphamide in the Treatment of Breast Cancer
Official Title: A Phase III Study of DPPE Combined With Epirubicin and Cyclophosphamide vs Epirubicin and Cyclophosphamide Alone as First Line Treatment in Metastatic/Recurrent Breast Cancer
Study ID: NCT00099281
Brief Summary: The purpose of this trial is to study DPPE combined with epirubicin and cyclophosphamide in patients with metastatic and/or recurrent breast cancer who may have received previous hormone treatment but have not had exposure to anthracycline treatment. Stratification allocation will be within the following subgroups: 1. Prior cytotoxic treatment; 2. Estrogen receptor status; 3. ECOG performance status; 4. Number of cycles of chemotherapy.
Detailed Description: Endpoints of the trial are as follows: primary: overall survival; secondary: response rate, progression free survival, toxicity, neurocognitive function.
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
PharmOlam, London, , United Kingdom
Name: Kathleen Pritchard, MD
Affiliation: Sunnybrook Health Sciences Centre
Role: STUDY_CHAIR