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

Phase 2TerminatedNCT00780000

Bristol-Myers Squibb4 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

AlvespimycinDRUG

Solution, IV, Alvespimycin 80 mg/m2, Weekly one hour infusion Days 1, 8, and 15, every 4 weeks thereafter until disease progression or DLT

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Objective tumor response rate (either RECIST or WHO complete response, partial response or minor response) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions