A Prospective Study to Evaluate Alterations in Molecular Biomarkers in HER2 Neu Positive Metastatic Breast Cancer Together With Assessment of Trastuzumab Use Beyond Progression After Initial Response to Trastuzumab-taxane Based Treatment
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Prospective Study to Evaluate Alterations in Molecular Biomarkers in HER2 Neu Positive Metastatic Breast Cancer Together With Assessment of Trastuzumab Use Beyond Progression After Initial Response to Trastuzumab-taxane Based Treatment
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression
Outcome Time Frame:
Event driven--monitored at each clinic visit
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Australia: National Health and Medical Research Council
Study ID:
MO22004
NCT ID:
NCT00885755
Start Date:
August 2009
Completion Date:
April 2014
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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