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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

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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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NSABP Foundation Inc

Study Description
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Brief Summary:

RATIONALE: Removing the sentinel lymph nodes and examining them under a microscope may help plan more effective surgery for breast cancer. It is not yet known if surgery to remove the sentinel lymph nodes is more effective with or without removal of the lymph nodes in the armpit in treating breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women who have breast cancer.


Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: conventional surgery Procedure: Sentinel node resection followed by node examination Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5611 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients
Study Start Date : May 1999
Actual Primary Completion Date : September 2010
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm I: Conventional axillary dissection
Sentinel node resection immediately followed by axillary dissection
 Procedure: conventional surgery
Sentinel node resection immediately followed by axillary dissection.
Experimental: Arm II: Sentinel node resection followed by node examination
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.
 Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Morbidity - Number of Participants With Residual Shoulder Abduction Deficit [ Time Frame: Before and after surgery (within 30 days of randomization) ]
    Morbidity as measured by residual shoulder abduction deficit. Shoulder Abduction Deficit definition: Shoulder range of motion decreased by greater than or equal to 10% as compared with that measured prior to surgery.

  2. Morbidity - Number of Participants With Residual Arm Volume Difference [ Time Frame: before and after surgery (within 30 days of randomization) ]
    Morbidity as measured by residual arm volume difference. Residual Arm Volume Difference definition: Arm volume differences greater than or equal to 10% as compared with that measured prior to surgery

  3. Morbidity - Number of Participants With Residual Arm Numbness [ Time Frame: before and after surgery (within 30 days of randomization) ]
    Morbidity as measured by residual arm numbness

  4. Morbidity - Number of Participants With Residual Arm Tingling [ Time Frame: before and after surgery (within 30 days of randomization) ]
    Morbidity as measured by residual arm tingling

  5. Overall Survival [ Time Frame: 8 years ]
    Measured at the time from randomization to any death to determine the percentage of patients alive at 8 years

  6. 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 ]
    Measured at time from randomization to recurrence, second primary, or death to determine the percentage of patients disease free at 8 years.


Secondary Outcome Measures :
  1. 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 ]
    Percentage of patients distant disease-free at 5 years. Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.

  2. 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 ]
    Measured at time from randomization to any distant cancer or death to determine percentage of patients distant disease free at 5 years. Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.

  3. 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) ]
    Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.

  4. Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases. [ Time Frame: At time of surgery (within 30 days of randomization) ]
    Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Resectable invasive adenocarcinoma of the breast, confirmed by 1 of the following:

    • Histologically confirmed by core or open biopsy
    • Confirmed by fine needle aspiration cytology AND positive clinical breast examination and ultrasound or mammography

  • Clinically negative lymph nodes

    • No positive ipsilateral axillary lymph nodes
    • No prior removal of ipsilateral axillary lymph nodes
    • No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven nonmalignant by biopsy

  • No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude

    • Tethering or dimpling of the skin or nipple inversion allowed
  • No bilateral malignancy or mass in the opposite breast that is suspicious for malignancy, unless proven nonmalignant by biopsy
  • No diffuse tumors or multiple malignant tumors in different quadrants of the breast
  • No other prior breast malignancy except lobular carcinoma in situ
  • No prior or concurrent breast implants

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 years and older

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • At least 10 years (excluding diagnosis of cancer)

Hematopoietic:

  • Not specified

Hepatic:

  • No hepatic systemic disease

Renal:

  • No renal systemic disease

Cardiovascular:

  • No cardiovascular systemic disease

Other:

  • No prior malignancy within past 5 years except:

    • Effectively treated squamous cell or basal cell skin cancer
    • Surgically treated carcinoma in situ of the cervix
    • Surgically treated lobular carcinoma in situ of the ipsilateral or contralateral breast
  • No concurrent psychiatric or addictive disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy for this cancer

Chemotherapy:

  • No prior chemotherapy for this cancer, including neoadjuvant chemotherapy

Endocrine therapy:

  • No prior hormonal therapy for this cancer

Radiotherapy:

  • No prior radiotherapy for this cancer

Surgery:

  • See Disease Characteristics
  • No prior breast reduction surgery
  • Prior excisional biopsy or lumpectomy allowed
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003830


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Sponsors and Collaborators
NSABP Foundation Inc
National Cancer Institute (NCI)
Investigators
Principal Investigator: Norman Wolmark, MD NSABP Foundation Inc
More Information
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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 Posted: January 28, 2003    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: November 2017

Keywords provided by NSABP Foundation Inc:
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases