Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer
|ClinicalTrials.gov Identifier: NCT01313039|
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : July 2, 2014
Last Update Posted : February 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: AZ6244||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer|
|Study Start Date :||February 2011|
|Primary Completion Date :||April 2014|
|Study Completion Date :||April 2014|
AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
Other Name: AZD6244
- Increase of ER Protein Expression in ER-Negative/Low Breast Cancer [ Time Frame: 2 years ]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 ]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 ]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 ]To assess for in vitro tamoxifen response in tumors following therapy with AZD6244.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|