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Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Richard R. Love, International Breast Cancer Research Foundation
ClinicalTrials.gov Identifier:
NCT00293540
First received: February 15, 2006
Last updated: June 28, 2016
Last verified: June 2016
Results First Received: May 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Procedure: oophorectomy
Drug: Tamoxifen

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
A Mid-luteal Surgery No text entered.
B Mid-follicular Surgery No text entered.

Participant Flow:   Overall Study
    A Mid-luteal Surgery   B Mid-follicular Surgery
STARTED   122   127 
COMPLETED   115   119 
NOT COMPLETED   7   8 



  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.
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Reporting Groups
  Description
A Mid-luteal Surgery No text entered.
B Mid-follicular Surgery No text entered.
Total Total of all reporting groups

Baseline Measures
   A Mid-luteal Surgery   B Mid-follicular Surgery   Total 
Overall Participants Analyzed 
[Units: Participants]
 115   119   234 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.0  (5.4)   38.6  (5.7)   38.8  (5.6) 
Gender 
[Units: Participants]
     
Female   115   119   234 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Vietnam   1   0   1 
Bangladesh   50   48   98 
Morocco   0   1   1 
Philippines   28   26   54 
China   21   27   48 
Malaysia   3   3   6 
Nigeria   6   6   12 
Indonesia   3   4   7 
Taiwan   3   4   7 
Dominant metastatic site 
[Units: Participants]
     
Soft tissue   76   83   159 
Bone   20   25   45 
Viscera   19   11   30 


  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: Up to 9 years ]


  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
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  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: Richard R. Love, MD
Organization: International Breast Cancer Research Foundation
phone: 608-698-7881
e-mail: richardibcrf@gmail.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Richard R. Love, International Breast Cancer Research Foundation
ClinicalTrials.gov Identifier: NCT00293540     History of Changes
Other Study ID Numbers: OSU-0476
Study First Received: February 15, 2006
Results First Received: May 19, 2016
Last Updated: June 28, 2016