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Trial record 1 of 1 for:    NCT01027416
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Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT01027416
Recruitment Status : Completed
First Posted : December 8, 2009
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Drug: Tamoxifen

  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
No Intervention No Intervention: Standard of care
Tamoxifen

Tamoxifen 20 mg orally 1x/day for 4 weeks

Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks


Participant Flow:   Overall Study
    No Intervention   Tamoxifen
STARTED   31   28 
COMPLETED   30   23 
NOT COMPLETED   1   5 
Withdrawal by Subject                0                1 
Physician Decision                1                4 



  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.
All treated and eligible patients.

Reporting Groups
  Description
No Intervention No Intervention: Standard of care
Tamoxifen

Tamoxifen 20 mg orally 1x/day for 4 weeks

Tamoxifen: Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks

Total Total of all reporting groups

Baseline Measures
   No Intervention   Tamoxifen   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   28   59 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      25  80.6%      19  67.9%      44  74.6% 
>=65 years      6  19.4%      9  32.1%      15  25.4% 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.7  (11.1)   58.5  (12.4)   57.0  (11.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      31 100.0%      28 100.0%      59 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
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      3   9.7%      4  14.3%      7  11.9% 
White      27  87.1%      23  82.1%      50  84.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   3.2%      1   3.6%      2   3.4% 


  Outcome Measures

1.  Primary:   Mean Percent Positive Proximity Ligation Assays of All Tumor Protein p53-wild Type Breast Tumors in Participants by Treatment Arm   [ Time Frame: 2 years ]

2.  Secondary:   Total Number of Over-expressed Genes, Across All Participants With Tumor Protein p53-wild Type Breast Tumors That Had RNA Samples Available.   [ Time Frame: 2 years ]


  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: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01027416     History of Changes
Obsolete Identifiers: NCT01658566
Other Study ID Numbers: RPCI I 110907
R21CA137635-01A1 ( U.S. NIH Grant/Contract )
First Submitted: December 4, 2009
First Posted: December 8, 2009
Results First Submitted: October 10, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017