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Phase II Study of Dasatinib (BMS-354825) for Advanced 'Triple-negative' Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer, Metastasis

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Trial Information

Phase II Study of Dasatinib (BMS-354825) for Advanced 'Triple-negative' Breast Cancer

Inclusion Criteria:

- females, 18 or older

- recurrent or progressive locally advanced, or 'triple negative' metastatic breast

- paraffin-embedded tissue block must be available

- measurable disease

- prior chemotherapy with an anthracycline, a taxane, or both (neoadjuvant, adjuvant,
or metastatic setting)

- 0, 1 or 2 chemotherapies in the metastatic setting

- adequate organ function

Exclusion Criteria:

- Metastatic disease confined to bone only

- Symptomatic CNS metastasis

- Concurrent medical condition which may increase the risk of toxicity

- Unable to take oral medication

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Complete Response (CR) or Partial Response (PR)

Outcome Description:

Tumor response was defined as the number of participants whose best response was CR or PR, per the Response Evaluation Criteria in Solid Tumor (RECIST): CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.

Outcome Time Frame:

Baseline to end of study drug therapy (up to 65 weeks).

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

September 2008

Related Keywords:

  • Breast Cancer
  • Metastasis
  • Recurrent, locally-advanced, or 'triple negative' metastatic breast cancer
  • Breast Neoplasms
  • Neoplasm Metastasis



Mayo Clinic JacksonvilleJacksonville, Florida  32224
Montefiore Medical CenterBronx, New York  10467-2490
University Of Texas Md Anderson Cancer CtrHouston, Texas  77030
Dana-Farber Cancer InstBoston, Massachusetts  02115
Ucsf-Comprehensive Cancer CenterSan Francisco, California  94115