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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00410813 |
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.
Condition | Intervention | Phase |
Breast Cancer Metastatic Cancer |
Drug: dasatinib |
Phase II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Dasatinib |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone Metastasis Predominant Metastatic Breast Cancer |
Estimated Enrollment: | 80 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Arm I: Experimental
Patients receive oral dasatinib once daily.
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Drug: dasatinib
given orally
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Arm II: Experimental
Patients receive oral dasatinib twice daily.
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Drug: dasatinib
given orally
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of breast carcinoma meeting the following criteria:
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:
Nonmeasurable disease with rising serum CA 15-3 or CA 27-29 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
Hormone receptor status known
PATIENT CHARACTERISTICS:
No uncontrolled concurrent condition that would preclude the ability to take oral medication, including the following:
No clinically significant cardiac disease, including the following:
PRIOR CONCURRENT THERAPY:
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:
Show 112 Study Locations |
Southwest Oncology Group |
National Cancer Institute (NCI) |
Study Chair: | Anne F. Schott, MD | University of Michigan Cancer Center |
Investigator: | Catherine Van Poznak, MD | University of Michigan Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000520348, SWOG-S0622 |
First Received: | December 11, 2006 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00410813 |
Health Authority: | Unspecified |
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