Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer
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 Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer|
- Increase of ER Protein Expression in ER-Negative/Low Breast Cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- Changes in ER-regulated Gene Expression in E-negative/Low Breast Cancer [ Time Frame: 2 Years ] [ Designated as safety issue: No ]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.
- Rate of ER Promoter Methylation in ER-negative/Low Breast Cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- In Vitro Tamoxifen Response in Tumors [ Time Frame: 2 years ] [ Designated as safety issue: No ]To assess for in vitro tamoxifen response in tumors following therapy with AZD6244.
|Study Start Date:||February 2011|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
Other Name: AZD6244
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313039
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|Study Chair:||Judith Hurley, MD||University of Miami Sylvester Comprehensive Cancer Center|