Status:
COMPLETED
XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint. The study will ...
Eligibility Criteria
Inclusion
- women \>=18 years of age;
- newly diagnosed;
- infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.
Exclusion
- evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes;
- previous systemic or local primary treatment.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00127933
Start Date
August 1 2005
End Date
July 1 2009
Last Update
August 10 2011
Active Locations (38)
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1
Los Angeles, California, United States, 90057
2
Montebello, California, United States, 90640
3
Palm Springs, California, United States, 92262
4
San Diego, California, United States, 92123