Overview

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