The goal of this clinical research study is to learn if dasatinib can help prevent breast cancer from developing in the unaffected breast. Dasatinib is designed to decrease the activity of one or more proteins that are responsible for the uncontrolled growth of tumor cells. This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of leukemia. Its use in breast cancer patients in investigational. Up to 66 patients will take part in this multicenter study. Up to 60 will be enrolled at MD Anderson.
Study Drug Administration: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 3 study groups: * If you are in Group 1, you will take dasatinib 40mg once a day by mouth with water. * If you are in Group 2, you will take dasatinib 80mg once a day by mouth with water. * If you are in Group 3, you will not receive dasatinib. You will be given a study drug diary to complete. In the diary, you will record when you take the study drug. Study Visits: At Month 1: * You will be called by a nurse and asked about any drugs you are taking and side effects you may be having. * You will be asked about any drugs you may be taking and side effects you may be having. * Your drug diary will be reviewed. At Month 2 you will be called by a nurse and asked about any drugs you are taking and side effects you may be having. You will also be asked to review your drug diary. This call will take about 20 minutes At Month 3 (or if you leave the study early): * You will have a fine needle aspirate (FNA) of the breast for biomarker testing. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug. * Blood (about 2-3 tablespoons) will be drawn for biomarker testing. * You will be asked about any drugs you may be taking and side effects you may be having. * Your drug diary will be reviewed. Length of Study: You may remain on study for up to 3 months. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
26
Group 1: 40 mg by mouth once a day. Group 2: 80 mg by mouth once a day.
Duke University
Durham, North Carolina, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Change in Ki-67 in Breast Tissue of High-Risk Women
Change in Ki-67 measured in baseline and month 3 using contralateral breast Fine Needle Aspiration (FNA) samples. Samples evaluated by immunohistochemistry (IHC). Baseline and follow up Ki-67 values presented in percentage (%) of cell positive, change reflects difference in percentage. Ki-67 is measured as a continuous variable and a one-way ANOVA followed by Dunnett's multiple comparison test comparing the change of Ki-67 of each of the three treated groups with control.
Time frame: up to 3 months
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Evaluation of serum utilizing ELISA kits for IGFBP1
Time frame: up to 3 months
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Evaluation of serum utilizing ELISA kits for IGF1
Time frame: up to 3 months
To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway
Evaluation of serum utilizing ELISA kits for IGFBP3
Time frame: up to 3 months
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