Conditions: Breast Cancer Metastatic Cancer
Keywords: stage IV breast cancer male breast cancer recurrent breast cancer bone metastases
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 85
Healthy volunteers: no

Brief summary:
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This randomized phase II trial is studying two different schedules of dasatinib to compare how well they work in treating patients with stage IV breast cancer that has spread to the bone.

Detailed description:
OBJECTIVES:

* Compare the progression-free survival of patients with stage IV bone metastasis-predominant breast cancer treated with 1 of 2 treatment schedules of dasatinib.
* Compare the response rate (complete and partial, confirmed and unconfirmed) in patients treated with these regimens.
* Compare the MUC-1 antigen response rate (CA 15-3 or CA 27-29) in patients treated with these regimens.
* Compare the circulating tumor cell response rate in patients treated with these regimens.
* Compare the anti-osteoclast activity, as measured by changes in bone turnover markers, in patients treated with these regimens.
* Compare the frequency and severity of toxicities of these regimens in these patients.
* Compare the pain profiles of these patients and explore changes over time.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent trastuzumab (Herceptin®) treatment (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral dasatinib once daily.
* Arm II: Patients receive oral dasatinib twice daily. In both treatment arms, treatment continues for at least 24 weeks in the absence of disease progression or unacceptable toxicity.

Blood samples are acquired from patients once weekly in weeks 1, 4, 8, 16, and 24. Samples are analyzed for tumor markers, circulating tumor cells, and bone markers.

Patients complete a self-reported brief pain inventory questionnaire at baseline and once in weeks 8, 16, and 24.

After completion of study treatment, patients are followed every 3-6 months for up to 2 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Arms:
arm 1: Patients receive oral dasatinib once daily. arm 2: Patients receive oral dasatinib twice daily.

Interventions: intervention 1: dasatinib
Intervention descriptions: intervention 1: given orally

Protocol document: