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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00037 | Registry Identifier | NCI CTRP | |
| KG09 1020 | Other Identifier | Susan G. Komen Breast Cancer Foundation |
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| Name | Class |
|---|---|
| Susan G. Komen Breast Cancer Foundation | OTHER |
| Bristol-Myers Squibb | INDUSTRY |
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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:
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:
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):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Dasatinib 40 mg | Experimental | Dasatinib 40 mg by mouth once a day for 3 months (+/- 7 days), At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. |
|
| Group 3: No Dasatinib | No Intervention | No treatment control group. At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. | |
| Group 2: Dasatinib 80 mg | Experimental | Dasatinib 80 mg by mouth once a day for 3 months (+/- 7 days). At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Group 1: 40 mg by mouth once a day. Group 2: 80 mg by mouth once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 3 months |
| To Evaluate Dasatinib Induced Modulation of Biomarker in the Serum Including Insulin Like Growth Factor (IGF) Pathway |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Banu Arun, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27708 | United States | ||
| University of Texas MD Anderson Cancer Center |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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26 patients were enrolled by 08/13/2018, of which were 24 randomized, 6 in No Treatment/Control, 12 in Dasatinib 40 mg, and 6 in Dasatinib 80 mg.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Dasatinib 40 mg | Dasatinib 40 mg by mouth once a day for 3 months (+/- 7 days), At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. Dasatinib: Group 1: 40 mg by mouth once a day. Dasatinib Group 2: 80 mg by mouth once a day. |
| FG001 | Group 2: Dasatinib 80 mg | Dasatinib 80 mg by mouth once a day for 3 months (+/- 7 days). At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. Dasatinib: Group 1: 40 mg by mouth once a day. Dasatinib Group 2: 80 mg by mouth once a day. |
| FG002 | Group 3: No Dasatinib | No treatment control group. At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Dasatinib 40 mg | Dasatinib 40 mg by mouth once a day for 3 months (+/- 7 days), At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. Dasatinib: Group 1: 40 mg by mouth once a day. Dasatinib Group 2: 80 mg by mouth once a day. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | FNA yield for matched pre-and-post treatment FNA samples was technically insufficient for Ki-67 immunohistochemitry analysis | Posted | up to 3 months |
|
Up to 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Dasatinib 40 mg | Dasatinib 40 mg by mouth once a day for 3 months (+/- 7 days), At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. Dasatinib: Group 1: 40 mg by mouth once a day. Dasatinib Group 2: 80 mg by mouth once a day. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arun K. Banu | M D Anderson Cancer Center | (713) 792-2817 | barun@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2017 | Jun 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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Evaluation of serum utilizing ELISA kits for IGF1 |
| 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 | up to 3 months |
| Houston |
| Texas |
| 77030 |
| United States |
| Group 2: Dasatinib 80 mg |
Dasatinib 80 mg by mouth once a day for 3 months (+/- 7 days). At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. Dasatinib: Group 1: 40 mg by mouth once a day. Dasatinib Group 2: 80 mg by mouth once a day. |
| BG002 | Group 3: No Dasatinib | No treatment control group. At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Group 2: Dasatinib 80 mg | Dasatinib 80 mg by mouth once a day for 3 months (+/- 7 days). At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. Dasatinib: Group 1: 40 mg by mouth once a day. Dasatinib Group 2: 80 mg by mouth once a day. |
| OG002 | Group 3: No Dasatinib | No treatment control group. At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. |
|
| Secondary | 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 | Posted | Mean | Standard Deviation | pg/ml | up to 3 months |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | ng/ml | up to 3 months |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | ng/ml | up to 3 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 11 |
| 12 |
| EG001 | Group 2: Dasatinib 80 mg | Dasatinib 80 mg by mouth once a day for 3 months (+/- 7 days). At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. Dasatinib: Group 1: 40 mg by mouth once a day. Dasatinib Group 2: 80 mg by mouth once a day. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | Group 3: No Dasatinib | No treatment control group. At the end of the 3 months (+/- 7 days) participants undergo a repeat FNA and blood collection for the same marker analyses. | 0 | 6 | 0 | 6 | 0 | 6 |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - (Other), specify | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - (Other), specify | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Specify (Other) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal and urinary disorders - (Other), specify | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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