Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer
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|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|
|Actual Primary Completion Date :||April 2014|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|