Status:
COMPLETED
A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This single arm study will evaluate alterations in molecular marker expression in HER2-positive targeted therapy, and will evaluate the effect of continued treatment with Herceptin and Xeloda beyond p...
Eligibility Criteria
Inclusion
- female patients, \>=18 years of age;
- HER2-positive breast cancer;
- al least one metastatic site amenable for core biopsy;
- left ventricular ejection fraction \>50%.
Exclusion
- prior adjuvant/neoadjuvant Herceptin within past 6 months;
- prior adjuvant taxane therapy within past 12 months;
- use of chemotherapy, immunotherapy or biological anticancer therapy within past 3 weeks;
- known bleeding diatheses.
Key Trial Info
Start Date :
August 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2013
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00885755
Start Date
August 13 2009
End Date
February 18 2013
Last Update
March 29 2018
Active Locations (13)
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1
Royal Prince Alfred Hospital; Medical Oncology
Camperdown, New South Wales, Australia, 2050
2
Royal North Shore Hospital; Oncology
St Leonards, New South Wales, Australia, 2065
3
Eastern Health Breast Cancer Research
East Ringwood, Victoria, Australia, 3135
4
Border Medical Oncology; Murray Valley Private Hospital
Wodonga, Victoria, Australia, 3690