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

Conditions

• Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Capecitabine — DRUG
  1000 mg/m² PO BID on Days 1-15 of each 3-week cycle
• Bevacizumab — DRUG
  15 mg IV on Day 1 of each 3-week cycle

Study Details

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 Dates

First listed

Jul 21, 2005

Start date

Jun 30, 2005

Status verified

Apr 2011

Primary completion

Dec 31, 2008

Completion

Dec 31, 2008

Study Design

Enrollment

109 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 1

Primary Outcome Measure

Overall Survival [ Time Frame: approximately 505 days (Median Time to Death) ]

Locations (57)

Find similar trials in Birmingham, AL

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