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

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.
ClinicalTrials.gov Identifier: NCT00293540
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : June 28, 2016
Last Update Posted : July 27, 2016
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
Interventions: Procedure: oophorectomy
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
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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
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 

  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.
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Reporting Groups
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 
[Units: Years]
Mean (Standard Deviation)
 39.0  (5.4)   38.6  (5.7)   38.8  (5.6) 
[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

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

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
First Submitted: February 15, 2006
First Posted: February 17, 2006
Results First Submitted: May 19, 2016
Results First Posted: June 28, 2016
Last Update Posted: July 27, 2016