Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases (23-01)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00072293
First received: November 4, 2003
Last updated: April 12, 2016
Last verified: April 2016
Results First Received: February 26, 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: Axillary lymph node dissection
Procedure: No axillary lymph node dissection

  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
Accrual began April 1, 2001 and closed February 28, 2010, after 934 patients from 27 centers in Europe, South America and Australia were randomized.

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
Axillary Dissection

Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.

Axillary lymph node dissection: Axillary lymph node dissection

No Axillary Dissection

Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.

No axillary lymph node dissection: Therapeutic conventional surgery


Participant Flow:   Overall Study
    Axillary Dissection     No Axillary Dissection  
STARTED     465     469  
COMPLETED     464     467  
NOT COMPLETED     1     2  
Lost to Follow-up                 1                 1  
Withdrawal by Subject                 0                 1  



  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.
Intention-to-treat

Reporting Groups
  Description
Axillary Dissection

Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.

Axillary lymph node dissection: Axillary lymph node dissection

No Axillary Dissection

Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.

No axillary lymph node dissection: Therapeutic conventional surgery

Total Total of all reporting groups

Baseline Measures
    Axillary Dissection     No Axillary Dissection     Total  
Number of Participants  
[units: participants]
  464     467     931  
Age  
[units: years]
Median (Inter-Quartile Range)
  53   (28 to 81)     54   (26 to 81)     54   (26 to 81)  
Gender  
[units: participants]
     
Female     464     467     931  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   5-year Disease-Free Survival   [ Time Frame: 5-year estimate reported after a median follow-up of 60 months ]

2.  Secondary:   5-year Overall Survival   [ Time Frame: 5-year estimate reported after a median follow-up of 60 months ]

3.  Secondary:   Site of Recurrence   [ Time Frame: Reported after a median follow-up of 60 months ]


  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:  
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: Rudolf Maibach, Executive Officer for International Trial Activities
Organization: IBCSG
phone: +41 31 389 91 96
e-mail: rudolf.maibach@ibcsg.org


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

Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00072293     History of Changes
Other Study ID Numbers: CDR0000339581
IBCSG 23-01 ( Other Identifier: IBCSG )
Study First Received: November 4, 2003
Results First Received: February 26, 2016
Last Updated: April 12, 2016
Health Authority: United States: Federal Government