4-Hydroxytamoxifen or Tamoxifen Citrate in Treating Women With Newly Diagnosed Ductal Breast Carcinoma in Situ

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Seema Khan, Northwestern University
ClinicalTrials.gov Identifier:
NCT00952731
First received: August 4, 2009
Last updated: July 18, 2015
Last verified: July 2015
Results First Received: May 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Ductal Breast Carcinoma in Situ
Estrogen Receptor-positive Breast Cancer
Interventions: Drug: oral placebo
Drug: afimoxifene
Drug: tamoxifen citrate
Drug: placebo gel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between November 2009 and July 2011, subjects were recruited at Northwestern University and Washington University. The original accrual goal was 112, however, the study was halted early due to drug supply issues.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 31 subjects were registered to the study but only 27 were randomized and began the study. Three participants were deemed ineligible and 1 withdrew consent before randomization.

Reporting Groups
  Description
Treatment Gel + Oral Placebo

4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.

oral placebo: Oral placebo taken daily for 4-10 weeks.

afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.

Placebo Gel + Oral Treatment

Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).

tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.

placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.


Participant Flow:   Overall Study
    Treatment Gel + Oral Placebo     Placebo Gel + Oral Treatment  
STARTED     13     14  
Randomization     13     14  
Treatment & Pre-Surgery     12     14  
Surgery     12     14  
Follow-up     12     14  
COMPLETED     12     14  
NOT COMPLETED     1     0  
Drug supply expired                 1                 0  



  Baseline Characteristics
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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
Treatment Gel + Oral Placebo

4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.

oral placebo: Oral placebo taken daily for 4-10 weeks.

afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.

Placebo Gel + Oral Treatment

Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).

tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.

placebo gel: Placebo gel applied to breasts daily for 4-10 weeks.

Total Total of all reporting groups

Baseline Measures
    Treatment Gel + Oral Placebo     Placebo Gel + Oral Treatment     Total  
Number of Participants  
[units: participants]
  13     14     27  
Age, Customized  
[units: participants]
     
40-49 years     1     2     3  
50-59 years     4     7     11  
60-69 years     6     4     10  
70-79 years     0     1     1  
80-89 years     2     0     2  
Gender  
[units: participants]
     
Female     13     14     27  
Male     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     4     7     11  
White     8     6     14  
More than one race     0     0     0  
Unknown or Not Reported     0     1     1  
Region of Enrollment  
[units: participants]
     
United States     13     14     27  
Menopausal status  
[units: participants]
     
Pre-Menopausal     4     3     7  
Post-Menopausal     9     11     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment   [ Time Frame: Baseline and after 4-10 weeks of treatment ]

2.  Secondary:   Difference in Mean Score for Vasomotor Symptoms Including Hot Flashes From Baseline to Time of Surgery   [ Time Frame: Baseline and after 4-10 weeks of treatment ]

3.  Secondary:   Difference in vWF Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery   [ Time Frame: Baseline to immediately before surgery (after approximately 4-10 weeks) ]

4.  Secondary:   Difference in Factor VIII Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery   [ Time Frame: Baseline and immediately before surgery (after approximately 4-10 weeks) ]

5.  Secondary:   Difference in Factor IX Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery   [ Time Frame: Baseline and immediately before surgery (after approximately 4-10 weeks) ]

6.  Secondary:   Difference in Protein S Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery   [ Time Frame: Baseline and immediately before surgery (after approximately 4-10 weeks) ]

7.  Other Pre-specified:   Compare Concentrations of Tamoxifen and Its Metabolites (4-hydroxytamoxifen, Endoxifen, N-desmethyl Tamoxifen (NDT)) Obtained From Samples on the Day of Surgery   [ Time Frame: Day of surgery (after approximately 4-10 weeks) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Other Pre-specified:   Drug Metabolite Levels in the Two Study Groups by CYP2D6 Polymorphism Status   [ Time Frame: 28-70 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Other Pre-specified:   4-OHT Affects Known Tamoxifen-modulated Pathways   [ Time Frame: 28-70 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Other Pre-specified:   TAM Metabolite Concentrations and Estrogen Response Markers in Nipple Aspiration Fluid (NAF)   [ Time Frame: 28-70 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Other Pre-specified:   E and Z 4-OHT Isomers   [ Time Frame: 28-70 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The study was originally designed to enroll 112 participants, unfortunately, the shelf-life of the study drug expired which resulted in early closure of the study after only 31 participants.


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


Results Point of Contact:  
Name/Title: Dr. Seema Khan
Organization: Northwestern University
phone: 312-503-4236
e-mail: s-khan2@northwestern.edu


No publications provided


Responsible Party: Seema Khan, Northwestern University
ClinicalTrials.gov Identifier: NCT00952731     History of Changes
Other Study ID Numbers: NWU07-9-02, NCI-2013-00452, NCI 07-9-02, NCI-2013-00452, P30CA060553, N01CN35157
Study First Received: August 4, 2009
Results First Received: May 27, 2015
Last Updated: July 18, 2015
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Institutional Review Board