Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Treatment Closed 18 and over Pharmaceutical / Industry ML18527 NCT00121836

Trial Description

Summary

This single arm study will evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first line treatment in women with metastatic breast cancer. Patients will receive Xeloda 1000mg/m2 po bid on days 1-15, and Avastin 15mg iv on day 1, of each 3 week cycle.The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Eligibility Criteria

Inclusion Criteria:

• women >=18 years of age;

• HER2-negative metastatic breast cancer;

• previous adjuvant chemotherapy or hormonal treatment;

• >=1 measurable target lesion.

Exclusion Criteria:

• previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy for advanced or metastatic cancer;

• radiation therapy within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiation therapy;

• central nervous system metastases;

• other malignancy within last 5 years, except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix;

• serious concurrent infection.

Trial Contact Information

Trial Lead Organizations/Sponsors

F. Hoffmann - La Roche, Limited

Clinical Trials

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00121836
Information obtained from ClinicalTrials.gov on October 16, 2008