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Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance (POWER PIINC)

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ClinicalTrials.gov Identifier: NCT01614210
Recruitment Status : Completed
First Posted : June 7, 2012
Results First Posted : December 13, 2017
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Utah

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Newly Diagnosed Hormone Positive Clinical Stage 1 or 2 Breast Cancer
Interventions: Drug: Tamoxifen
Procedure: Breast cancer surgery

  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
Tamoxifen Pre and Post Breast Surgery

All patients enrolled in the study.

Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.

Breast cancer surgery: Breast cancer surgery


Participant Flow:   Overall Study
    Tamoxifen Pre and Post Breast Surgery
STARTED   52 
COMPLETED   52 
NOT COMPLETED   0 



  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
Tamoxifen Pre and Post Breast Surgery

All patients enrolled in the study.

Tamoxifen: All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.

Breast cancer surgery: Breast cancer surgery


Baseline Measures
   Tamoxifen Pre and Post Breast Surgery 
Overall Participants Analyzed 
[Units: Participants]
 52 
Age 
[Units: Years]
Median (Full Range)
 58.5 
 (38 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      52 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   52 


  Outcome Measures

1.  Primary:   Change in Ki67 Expression in Tumors   [ Time Frame: 7 days ]

2.  Secondary:   Correlation Between Changes in Ki67 and Symptoms   [ Time Frame: 7 days ]

3.  Other Pre-specified:   Change in FACT-ES Symptom Scores   [ Time Frame: 7 days ]

4.  Secondary:   Evaluate Symptom Patterns   [ Time Frame: 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Adherence   [ Time Frame: 18 months ]
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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mark Wade
Organization: Huntsman Cancer Institute
phone: 8012135746
e-mail: mark.wade@hci.utah.edu



Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01614210     History of Changes
Other Study ID Numbers: HCI57098
First Submitted: June 4, 2012
First Posted: June 7, 2012
Results First Submitted: July 28, 2017
Results First Posted: December 13, 2017
Last Update Posted: April 2, 2018