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Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/Neu-Positive Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Metastasis

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Trial Information

Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/Neu-Positive Breast Cancer


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

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 Objective Response

Outcome Description:

Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.

Outcome Time Frame:

From day of first treatment through Week 25 or at time of discontinuation from study treatment.

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-088

NCT ID:

NCT00371345

Start Date:

December 2006

Completion Date:

May 2009

Related Keywords:

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

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Montefiore Medical CenterBronx, New York  10467-2490
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
University Of Texas Md Anderson Cancer CtrHouston, Texas  77030
Dana-Farber Cancer InstBoston, Massachusetts  02115
Ucsf-Comprehensive Cancer CenterSan Francisco, California  94115
Mayo Clinic FloridaJacksonville, Florida  32224