Status:

COMPLETED

Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Breast Cancer

Metastasis

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer

Eligibility Criteria

Inclusion

  • females, 18 or older
  • recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu
  • paraffin-embedded tissue block must be available
  • measurable disease
  • prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or metastatic setting)
  • 0, 1 or 2 chemotherapies in the metastatic setting
  • adequate organ function

Exclusion

  • Metastatic disease confined to bone only
  • Symptomatic central nervous system (CNS) metastasis
  • Concurrent medical condition which may increase the risk of toxicity
  • Unable to take oral medication

Key Trial Info

Start Date :

December 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2009

Estimated Enrollment :

92 Patients enrolled

Trial Details

Trial ID

NCT00371345

Start Date

December 1 2006

End Date

May 1 2009

Last Update

April 26 2011

Active Locations (23)

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Page 1 of 6 (23 locations)

1

Ucsf-Comprehensive Cancer Center

San Francisco, California, United States, 94143

2

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

3

Dana-Farber Cancer Inst

Boston, Massachusetts, United States, 02115

4

Montefiore Medical Center

The Bronx, New York, United States, 10461