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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Metastasis

Treatments: Drug: Dasatinib; Drug: Dasatinib 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00371345

CA180-088

Details and patient eligibility

About

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

Enrollment: 92 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

Dasatinib

Experimental group

Description:

Participants with either a Human epidermal growth factor (Her2/neu)-amplified tumor type or ER and/or PgR positive tumor types received oral dasatinib twice daily (BID).

Treatment:

Drug: Dasatinib

Drug: Dasatinib 100 mg