Status:
TERMINATED
Clinical Trial of Intravenous Alvespimycin in Patients With Her2 Positive Breast Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the anti-tumor activity (via objective response rate) of alvespimycin in patients with breast cancer who have not previously received trastuzumab (except as a...
Eligibility Criteria
Inclusion
- KPS performance status of \>= 80% ("normal activity with effort")
- Metastatic breast cancer with Her2 amplification by FISH or 3+ Her2 overexpression by immunohistochemistry ("IHC")
- Must have received no more than one prior cytotoxic chemotherapy regimen in the metastatic setting
- Measurable disease by RECIST Criteria
Exclusion
- Received prior lapatinib, an investigational ErbB-2 and/or an investigational EGFR dual tyrosine kinase inhibitors
- Administration of any other chemotherapy, biological, immunotherapy or investigational agent within 14 days prior to receipt of study medication
- Pregnant or breast-feeding women. Known CNS metastases, unless treated and without clinically significant neurological deficits
- Moderately severe dry eye
- Congestive heart failure, or a left ventricular ejection fraction
- Myocardial infarction or active ischemic heart disease within 12 months prior to study drug administration
- Previous malignancies unless free of recurrence for at least 5 years
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00780000
Start Date
April 1 2008
End Date
June 1 2008
Last Update
November 4 2015
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