Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Women With Advanced Breast Cancer

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Advanced Breast Cancer

Treatments: Drug: Capecitabine; Drug: Dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00452673

EUDRACT: 2006-006973-26

CA180-004

Details and patient eligibility

About

The purpose of this study is to learn about the safety and efficacy of Dasatinib in combination with Capecitabine for patients with advanced breast cancer, and who have received treatment with a taxane and an anthracycline

Enrollment: 52 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email [e-mail]. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

• Female with advanced breast cancer previously treated with a taxane and an anthracycline
• No pleural or pericardial effusion
• Not receiving anticoagulants

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

52 participants in 4 patient groups

50 mg BID dasatinib + 825 mg/m^2 BID capecitabine

Experimental group

Description:

Twice a day (BID) for 2 weeks of a 3-week cycle

Treatment:

Drug: Dasatinib

Drug: Capecitabine

70 mg BID dasatinib + 825 mg/m^2 BID capecitabine

Experimental group

Description:

BID for 2 weeks of a 3-week cycle

Treatment:

Drug: Dasatinib

Drug: Capecitabine

70 mg BID dasatinib + 1000 mg/m^2 BID capecitabine

Experimental group

Description:

BID for 2 weeks of a 3-week cycle

Treatment:

Drug: Dasatinib

Drug: Capecitabine

100 mg QD dasatinib + 1000 mg/m^2 BID capecitabine

Experimental group

Description:

2 weeks of a 3-week cycle

Treatment:

Drug: Dasatinib

Drug: Capecitabine