Dasatinib in Treating Patients With Stage IV Breast Cancer That Has Spread to the Bone
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone Metastasis Predominant Metastatic Breast Cancer|
- Disease progression, defined as an increase in measurable disease, the appearance of new lesions, and/or clinical deterioration related to disease progression [ Designated as safety issue: No ]
- MUC-1 antigen response at 4, 8, 16, and 24 weeks [ Designated as safety issue: No ]
- Change in serum bone turnover markers over time [ Designated as safety issue: No ]
- Circulating tumor cell response [ Designated as safety issue: No ]
- Incidence of grade 3-4 toxicity [ Designated as safety issue: Yes ]
- Response as measured by RECIST criteria [ Designated as safety issue: No ]
- Change in the primary measure "worst pain" on the Brief Pain Inventory at 8, 16, and 24 weeks [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral dasatinib once daily.
Experimental: Arm II
Patients receive oral dasatinib twice daily.
- 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.
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|Study Chair:||Anne F. Schott, MD||University of Michigan Cancer Center|
|Investigator:||Catherine Van Poznak, MD||University of Michigan Cancer Center|