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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
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Single Arm AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15

Participant Flow:   Overall Study
    Single Arm
STARTED   4 
COMPLETED   2 
NOT COMPLETED   2 
Physician Decision                1 
Adverse Event                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AZD6244 AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15

Baseline Measures
   AZD6244 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age 
[Units: Years]
Mean (Full Range)
 59.75 
 (56 to 70) 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      3  75.0% 
>=65 years      1  25.0% 
Gender 
[Units: Participants]
Count of Participants
 
Female      4 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   4 


  Outcome Measures

1.  Primary:   Increase of ER Protein Expression in ER-Negative/Low Breast Cancer   [ Time Frame: 2 years ]

2.  Secondary:   Changes in ER-regulated Gene Expression in E-negative/Low Breast Cancer   [ Time Frame: 2 Years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Rate of ER Promoter Methylation in ER-negative/Low Breast Cancer   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   In Vitro Tamoxifen Response in Tumors   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Only 4 patients were enrolled and of these 4 only 1 patient had evaluable study data.


  More Information

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
e-mail: JHurley@med.miami.edu



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