If AZD6244 is able to increase ER expression in ER-negative/low cancers then it may be possible to effectively use hormonal therapy in these patients resulting in improved outcomes. The investigators propose a single-arm Simon two-step study to examine whether treatment with AZD6244 will result in increased ER expression in ER-negative/low primary breast tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Increase of ER Protein Expression in ER-Negative/Low Breast Cancer
To evaluate in a clinical neoadjuvant model whether MEK inhibitor AZD6244 can increase ER protein expression in ER-negative/low breast cancer, as measured by the "ER response rate" by both standard immunohistochemistry and Allred Score.
Time frame: 2 years
Changes in ER-regulated Gene Expression in E-negative/Low Breast Cancer
To assess for changes in ER-regulated gene expression in ER-negative/low breast tumors following AZD6244 therapy through assessment of protein expression by immunhistochemistry in paraffin embedded tissues.
Time frame: 2 Years
Rate of ER Promoter Methylation in ER-negative/Low Breast Cancer
To determine the rate of ER promoter methylation in ER-negative/low breast cancer tumors that do not attain an ER response following AZD6244 therapy.
Time frame: 2 years
In Vitro Tamoxifen Response in Tumors
To assess for in vitro tamoxifen response in tumors following therapy with AZD6244.
Time frame: 2 years
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