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Therapeutic Areas: Oncology | Obstetrics/Gynecology
Disease Category: Breast Cancer
Trial Information
A Study of Xeloda (Capecitabine) in Patients With Advanced Breast Cancer
Status: Completed
Protocol Number: ML16505
Sponsor: Roche S.p.A. Italy
Company Division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the addition of oral Xeloda to intravenous Taxotere and epirubicin on progression-free survival in patients with advanced breast cancer
Brief Summary: This study will evaluate the efficacy and safety of oral Xeloda plus intravenousTaxotere and epirubicin, compared with the combination therapy alone. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is 340.
Study Phase: III
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Non-Randomized
- Masking: Open Label
- Control: Uncontrolled
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
Condition: Breast Cancer
Intervention Type: Drug
Intervention Name: capecitabine[Xeloda]
Primary Outcome: 1. Progression-free survival and overall survival
Key Secondary Outcomes: 1. Efficacy:Complete remission, partial remission, stable disease, progressive disease and overall survival. Safety: Adverse events and laboratory parameters
Inclusion Criteria:
- women 18-70 years of age;
- locally advanced or metastatic breast cancer (stage III or IV);
- >=1 measurable lesion.
Exclusion Criteria:
- prior chemotherapy for metastatic disease;
- clinically significant cardiac disease;
- history of cancer, other than non-melanoma skin cancer or cancer in situ of the cervix.
Gender: Females
Age Limits: Min: 18 Years Max: 70 Years
Accepts Healthy Volunteers: No
Trial Registration Date: 10/27/2005
Date Last Updated: 05/18/2009
Link To Trial Results
E-mail: genentechclinicaltrials@druginfo.com
Research Site:
Located In:
Cagliari 09121
Italy
Phone: 888-662-6728 (U.S. Only)
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