Expired Study
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Melbourne, Florida 32910


Purpose:

This single arm study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intravenous Taxotere (docetaxel) in patients with HER2-neu negative breast cancer, and in combination with iv Herceptin (trastuzumab) in patients with HER2-neu positive breast cancer. Patients will receive 3-weekly cycles of treatment with Xeloda (825mg/m2 po bid on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Criteria:

Inclusion Criteria: - women >=18 years of age; - newly diagnosed; - infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer. Exclusion Criteria: - evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes; - previous systemic or local primary treatment.


NCT ID:

NCT00127933


Primary Contact:

Study Director
Clinical Trials
Hoffmann-La Roche


Backup Contact:

N/A


Location Contact:

Melbourne, Florida 32910
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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