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Studying Blood Samples From Women With Breast Cancer or Ductal Carcinoma In Situ Who Are Receiving Tamoxifen (NRR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00764322
First Posted: October 2, 2008
Last Update Posted: August 1, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
Results First Submitted: March 31, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Breast Cancer
Menopausal Symptoms
Interventions: Drug: tamoxifen citrate
Genetic: gene expression analysis
Other: pharmacogenomic studies
Other: questionnaire administration
Procedure: quality-of-life assessment

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from breast cancer patients at Lineberger Comprehensive Cancer Center who had received tamoxifen for at least 4 months.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient was a screen failure

Reporting Groups
  Description
Patients Enrolled No text entered.

Participant Flow:   Overall Study
    Patients Enrolled
STARTED   500 
COMPLETED   480 
NOT COMPLETED   20 
Withdrawal by Subject                11 
No CYP2D6 genotyping                9 



  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
Extensive and Ultra-rapid Metabolizers Those with the highest endoxifen concentrations as measured at baseline.
Intermediate and Poor Metabolizers Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
Total Total of all reporting groups

Baseline Measures
   Extensive and Ultra-rapid Metabolizers   Intermediate and Poor Metabolizers   Total 
Overall Participants Analyzed 
[Units: Participants]
 161   319   480 
Age 
[Units: Years]
Median (Full Range)
     
Median       
Participants Analyzed 
[Units: Participants]
 161   319   480 
Median   51 
 (30 to 95) 
 50 
 (25 to 88) 
 50 
 (25 to 95) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 161   319   480 
Female      161 100.0%      319 100.0%      480 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 161   319   480 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      13   8.1%      61  19.1%      74  15.4% 
White      140  87.0%      250  78.4%      390  81.3% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      8   5.0%      8   2.5%      16   3.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States       
Participants Analyzed 
[Units: Participants]
 161   319   480 
United States   161   319   480 
Menopausal status 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 161   319   480 
Pre/peri-      70  43.5%      154  48.3%      224  46.7% 
Post-      91  56.5%      165  51.7%      256  53.3% 
Duration of Tamoxifen treatment (years) 
[Units: Years]
Median (Full Range)
     
Participants Analyzed 
[Units: Participants]
 161   319   480 
   0.88 
 (0.31 to 9.69) 
 0.98 
 (0.28 to 15.86) 
 0.93 
 (0.28 to 15.86) 
Prior chemotherapy 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 161   319   480 
Yes      92  57.1%      169  53.0%      261  54.4% 
No      69  42.9%      150  47.0%      219  45.6% 
Tamoxifen indication [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 161   318   479 
Invasive Disease      144  89.4%      263  82.7%      407  85.0% 
DCIS      17  10.6%      49  15.4%      66  13.8% 
Other      0   0.0%      6   1.9%      6   1.3% 
[1] One patient could not be included because indication was not supplied.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes   [ Time Frame: 4 months ]

2.  Secondary:   Number of Participants With Pulmonary Embolism (PE), Deep Vein Thrombosis (DVT), Stroke, and/or Endometrial Cancer   [ Time Frame: Approximately ten months from registration to last follow-up ]

3.  Secondary:   Change in Median Endoxifen Concentrations to Determine Feasibility of Obtaining Pharmacogenomic Information From Patients in the Clinical Setting and Using it to Guide Changes in Therapy   [ Time Frame: Baseline and 4 months after dose increase ]

4.  Secondary:   CYP2D6 Allele Frequencies and Endoxifen Levels Among African-American Women Taking Tamoxifen Citrate   [ Time Frame: baseline ]

5.  Secondary:   Change in Plasma Endoxifen Levels After an Increase in Tamoxifen Citrate Dose From 20 mg to 40 mg Daily in Patients With Poor-metabolizing Genotypes   [ Time Frame: Baseline and 4 months after dose increase ]

6.  Secondary:   Patient Understanding of Pharmacogenomics   [ Time Frame: baseline ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
phone: 919-966-1125
e-mail: Robin_V_Johnson@med.unc.edu



Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00764322     History of Changes
Other Study ID Numbers: LCCC 0801
P30CA016086 ( U.S. NIH Grant/Contract )
08-0483 ( Other Identifier: UNC Biomedical IRB )
First Submitted: October 1, 2008
First Posted: October 2, 2008
Results First Submitted: March 31, 2017
Results First Posted: July 2, 2017
Last Update Posted: August 1, 2017