A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-negative' Breast Cancer

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Metastasis

Treatments: Drug: Dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00371254

CA180-059

Details and patient eligibility

About

This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced triple-negative breast cancer.

Enrollment: 55 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• females, 18 or older
• recurrent or progressive locally advanced, or 'triple negative' metastatic breast cancer
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Dasatinib

Drug: Dasatinib

2

Experimental group

Treatment:

Drug: Dasatinib

Drug: Dasatinib