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About
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.
Full description
OBJECTIVES:
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.
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.
Enrollment
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Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Diagnosis of breast carcinoma meeting the following criteria:
Stage IV disease
Bone metastasis-predominant disease, defined as the presence of ≥ 1 bone metastasis with or without nonbone (visceral or soft tissue) disease where the number of bone metastases is at least the number of measurable visceral target lesions
Must meet 1 of the following criteria:
Measurable disease within the past 28 days
Nonmeasurable disease with rising serum CA 15-3, CA 27-29, CEA, or CA-125 documented by 2 consecutive measurements taken ≥ 14 days apart with the most recent measurement being within the past 42 days
No symptomatic brain or CNS metastases
No pleural or pericardial effusion
Hormone receptor status known
PATIENT CHARACTERISTICS:
Male or female
Menopausal status not specified
Zubrod performance status 0-2
QTc < 450 msec by EKG
Ejection fraction ≥ 50% by MUGA or 2-dimensional echocardiogram with no significant abnormalities within the past 12 weeks for patients on trastuzumab
No active infection requiring systemic therapy
No uncontrolled concurrent condition that would preclude the ability to take oral medication, including the following:
No clinically significant cardiac disease, including the following:
No concurrent active malignancy
Not pregnant or nursing
Fertile patients must use effective contraception during and for 3 months after completion of study therapy
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior RankL inhibitor therapy
No more than 1 prior cytotoxic chemotherapy for metastatic disease
At least 3 weeks since prior chemotherapy and recovered
At least 1 week since prior radiotherapy to non-CNS disease and recovered
At least 3 weeks since prior and no concurrent intravenous bisphosphates (e.g., zoledronate)
At least 7 days since prior and no concurrent antiplatelet agents, including any of the following*:
At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
At least 7 days since prior and no concurrent medications that prolong the QTc interval, including any of the following:
No other concurrent antineoplastic therapy for breast cancer, including any of the following:
No concurrent grapefruit juice consumption
No concurrent short-acting antacid agents within 2 hours of dasatinib administration
Concurrent trastuzumab (Herceptin®) therapy for HER-2 positive patients allowed provided patients have been on continuous trastuzumab for ≥ 12 weeks
Primary purpose
Allocation
Interventional model
Masking
85 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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