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Brief Title: BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer
Official Title: Phase III Multicenter Study of the Effects on Quality of Life of Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer
Study ID: NCT00540800
Brief Summary: Some chemotherapies, including docetaxel, are better tolerated and just as effective when giving the dose weekly rather than on an every three week basis. The purpose of this study is to compare 2 schedules of combination chemotherapy with docetaxel for the effects on quality of life. Standard every three week chemotherapy will be compared with weekly chemotherapy for metastatic or locally advanced breast cancer.
Detailed Description: Patients with locally advanced breast cancer and patients with metastatic breast cancer who have not previously received an anthracycline will be treated with docetaxel and epirubicin. Patients with metastatic breast cancer who have already received anthracyclines will be treated with docetaxel and capecitabine. All patients will be randomized to receive their treatment either on an every three week schedule, or on a weekly schedule.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B, Napoli, , Italy
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C, Napoli, , Italy
Ospedale S. Luca ASL SA 3, Vallo della Lucania, , Italy
Name: Andrea de Matteis, M.D.
Affiliation: NCI Naples, Division of Medical Oncology C
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Perrone, M.D., Ph.D.
Affiliation: NCI Naples, Clinical Trials Office
Role: PRINCIPAL_INVESTIGATOR