A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer

Completed · Phase 4

Conditions studied: Breast Cancer

In brief

This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was \<100 individuals.

Key facts

Study ID

NCT00121836

Run by

Hoffmann-La Roche

People needed

109

Starts

2005-06-01

Expected to finish

2008-12-01

Last updated by the study team

2011-04-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women >=18 years of age
• HER2-negative metastatic breast cancer
• Previous adjuvant chemotherapy or hormonal treatment
• >=1 measurable target lesion

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Burbank, California, United States
• Study site — Glendale, California, United States
• Study site — Glendale, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Farmington, Connecticut, United States
• Study site — Bonita Springs, Florida, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Bradenton, Florida, United States
• Study site — Cape Coral, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Port Charlotte, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Venice, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.