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A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer

NCT00089479 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2611

Last updated 2012-12-21

Study results available
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Summary

This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Conditions

Interventions

DRUG

capecitabine [Xeloda]

825mg/m2 po bid on days 1-14 of each 3 week cycle

DRUG

Taxotere

75mg/m2 iv on day 1 of each 3 week cycle

DRUG

Taxotere

100mg/m2 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
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2010-06-30
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

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 NCT00089479 on ClinicalTrials.gov