Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer
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:
- Blood (about 2 tablespoons) will be drawn for routine tests.
- 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.
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Change in Ki-67 in Breast Tissue of High-Risk Women
Primary endpoint is the change in Ki-67 before and after 3 months of dasatinib treatment in breast tissue of high-risk women. 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. The purpose of this study is to determine the minimum biological effective dose, which is defined as the lowest dose where the change of Ki-67 is significantly different from that in the control group.
3 months
No
Banu Arun, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2010-0794
NCT01471106
May 2013
Name | Location |
---|---|
Duke University | Durham, North Carolina 27710 |
UT MD Anderson Cancer Center | Houston, Texas 77030 |