ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Use of AZD6244 to Induce Increased ER Expression and Anti-Estrogen Response in ER-Negative/Low Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01313039
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : July 2, 2014
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
University of Miami

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: AZ6244
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm
Hide Arm/Group Description AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
Period Title: Overall Study
Started 4
Completed 2
Not Completed 2
Reason Not Completed
Physician Decision             1
Adverse Event             1
Arm/Group Title AZD6244
Hide Arm/Group Description AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
59.75
(56 to 70)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  75.0%
>=65 years
1
  25.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
4
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Increase of ER Protein Expression in ER-Negative/Low Breast Cancer
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 1 subject had evaluable study data
Arm/Group Title Single Arm
Hide Arm/Group Description:
AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
1
2.Secondary Outcome
Title Changes in ER-regulated Gene Expression in E-negative/Low Breast Cancer
Hide Description 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
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Rate of ER Promoter Methylation in ER-negative/Low Breast Cancer
Hide Description 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
Outcome Measure Data Not Reported
4.Secondary Outcome
Title In Vitro Tamoxifen Response in Tumors
Hide Description To assess for in vitro tamoxifen response in tumors following therapy with AZD6244.
Time Frame 2 years
Outcome Measure Data Not Reported
Time Frame Study results not evaluated due to low accrual.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm
Hide Arm/Group Description AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm
Affected / at Risk (%)
Total   0/4 (0.00%) 
Only 4 patients were enrolled and of these 4 only 1 patient had evaluable study data.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Judith Hurley MD
Organization: University of Miami Sylvester Comprehensive Cancer Center
Phone: 305-243-6462
Responsible Party: University of Miami
ClinicalTrials.gov Identifier: NCT01313039     History of Changes
Other Study ID Numbers: 20100252
First Submitted: March 9, 2011
First Posted: March 11, 2011
Results First Submitted: May 1, 2014
Results First Posted: July 2, 2014
Last Update Posted: February 7, 2017