Status:
COMPLETED
Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer
Lead Sponsor:
WiSP Wissenschaftlicher Service Pharma GmbH
Collaborating Sponsors:
Bristol-Myers Squibb
Roche Pharma AG
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials s...
Eligibility Criteria
Inclusion
- histologically confirmed metastatic breast cancer overexpressing HER2
- pretreatment with anthracycline in either the adjuvant or palliative setting.
- HER2 positivity was defined as 2+ or 3+ overexpression using the DAKO HercepTest, confirmed by fluorescence in-situ hybridization (FISH) if 2+.
- informed consent
Exclusion
- more than 1 chemotherapy for advanced disease
- taxane or trastuzumab pretreatment
- brain metastases
- Eastern Cooperative Oncology Group (ECOG) performance status \>1
- pregnancy or lactation, childbearing potential without reliable contraception
- clinically significant cardiac disease,
- neutrophils \<1500/µl, platelets \<75,000/µl
- total bilirubin and creatinine \>1.5 × the upper limit of normal
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01423695
Start Date
February 1 2001
End Date
December 1 2009
Last Update
August 26 2011
Active Locations (1)
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1
Dr. Matthias John
Glauchau, Saxony, Germany, D-08371