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;   Endpoint Classification: Efficacy Study;   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  
Number of Participants  
[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



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
Health Authority: United States: Institutional Review Board