Clinical Trial of Intravenous Alvespimycin in Patients With Her2 Positive Breast Cancer

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Female

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 adjuvant therapy).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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