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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Alvespimycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00780000

KDG-201 (Other Identifier)

2007-003121-25 (EudraCT Number)

CA201-002

Details and patient eligibility

About

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).

Enrollment: 4 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

A1

Experimental group

Treatment:

Drug: Alvespimycin