MedTrace Logo

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

NCT00121836 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2011-04-27

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

DRUG

Capecitabine

1000 mg/m² PO BID on Days 1-15 of each 3-week cycle

DRUG

Bevacizumab

15 mg IV on Day 1 of each 3-week cycle

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00121836 on ClinicalTrials.gov