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Phase 2 Clinical Trial of Intravenous Alvespimycin [KOS-1022] in Patients With Her2 Positive Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Phase 2 Clinical Trial of Intravenous Alvespimycin [KOS-1022] in Patients With Her2 Positive Breast Cancer

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

(all patients were off study by June 2008)

Outcome Time Frame:

Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


Russia: Ministry of Health of the Russian Federation

Study ID:




Start Date:

April 2008

Completion Date:

June 2008

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms