S0622, Dasatinib in Treating Patients With Stage IV Breast Cancer That Has

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00410813
Study type	Interventional
Source	Southwest Oncology Group
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	March 2007
Completion date	September 2013

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

S0622, Dasatinib in Treating Patients With Stage IV Breast Cancer That Has Spread to the Bone

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms