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Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With 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: NCT00003830
Recruitment Status : Completed
First Posted : January 28, 2003
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
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: conventional surgery
Procedure: Sentinel node resection followed by node examination

  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
Arm I: Conventional Axillary Dissection

Sentinel node resection immediately followed by axillary dissection

conventional surgery: Sentinel node resection immediately followed by axillary dissection.

Arm II: Sentinel Node Resection Followed by Node Examination

Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.

Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.


Participant Flow:   Overall Study
    Arm I: Conventional Axillary Dissection   Arm II: Sentinel Node Resection Followed by Node Examination
STARTED   2807   2804 
COMPLETED   1975   2011 
NOT COMPLETED   832   793 
No follow up data                3                0 
Sentinel node positive patients                829                793 



  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.
No text entered.

Reporting Groups
  Description
Conventional Axillary Dissection Sentinel Node Resection Followed by Conventional Axillary Dissection
Sentinel Node Resection Followed by Node Examination Sentinel node resection followed by node examination
Total Total of all reporting groups

Baseline Measures
   Conventional Axillary Dissection   Sentinel Node Resection Followed by Node Examination   Total 
Overall Participants Analyzed 
[Units: Participants]
 2807   2804   5611 
Age 
[Units: Years]
Mean (Standard Deviation)
 56  (11.2)   56  (11.0)   56  (11.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2807 100.0%      2804 100.0%      5611 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Morbidity - Number of Participants With Residual Shoulder Abduction Deficit   [ Time Frame: Before and after surgery (within 30 days of randomization) ]

2.  Primary:   Morbidity - Number of Participants With Residual Arm Volume Difference   [ Time Frame: before and after surgery (within 30 days of randomization) ]

3.  Primary:   Morbidity - Number of Participants With Residual Arm Numbness   [ Time Frame: before and after surgery (within 30 days of randomization) ]

4.  Primary:   Morbidity - Number of Participants With Residual Arm Tingling   [ Time Frame: before and after surgery (within 30 days of randomization) ]

5.  Primary:   Overall Survival   [ Time Frame: 8 years ]

6.  Primary:   Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event.   [ Time Frame: 8 years ]

7.  Secondary:   Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence   [ Time Frame: From the time of randomization until 5 years ]

8.  Secondary:   Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence   [ Time Frame: From the time of randomization until 5 years ]

9.  Secondary:   The Percentage of Technically Successful Sentinel Node Resections as Measured by the Proportion of Patients for Whom at Least One Sentinel Node is Identified.   [ Time Frame: At time of surgery (within 30 days of randomization) ]

10.  Secondary:   Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases.   [ Time Frame: At time of surgery (within 30 days of randomization) ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director, Department of Regulatory Affairs
Organization: NSABP Foundation, Inc
phone: 412-339-5300
e-mail: regulatory@nsabp.org


Publications of Results:
Land SR, Kopec JA, Lee M, et al.: Quality of life in breast cancer patients receiving sentinel-node (SN) biopsy alone or with axillary dissection (AD): results from NSABP protocol B-32. [Abstract] J Clin Oncol 26 (Suppl 15): A-9533, 2008.
Julian TB, Anderson SJ, Fourchotte V, et al.: Is completion axillary dissection always required after a positive sentinel node biopsy? NSABP B-32. [Abstract] Breast Cancer Res Treat 106 (1): A-51, S15, 2007.
Julian TB, Anderson SJ, Fourchotte V, et al.: Is intraoperative cytology of sentinel nodes useful and predictive for non-sentinel axillary nodes? NSABP B-32. [Abstract] Breast Cancer Res Treat 106 (1): A-3001, 2007.
Julian B, Fourchotte V, Anderson S, et al.: Predictive factors that identify patients not requiring a sentinel node biopsy: continued analysis of the NSABP B-32 sentinel node trial. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-2003, S80-1, 2006.

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

Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00003830     History of Changes
Other Study ID Numbers: NSABP B-32
U10CA012027 ( U.S. NIH Grant/Contract )
CDR0000066987
First Submitted: November 1, 1999
First Posted: January 28, 2003
Results First Submitted: May 4, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017