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NCT00003830 · CITED IN SOURCE DOCUMENTS

Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2017-12-13

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Morbidity - Number of Participants With Residual Shoulder Abduction Deficit

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outcome · POSTED

Morbidity - Number of Participants With Residual Arm Volume Difference

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outcome · POSTED

Morbidity - Number of Participants With Residual Arm Numbness

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outcome · POSTED

Morbidity - Number of Participants With Residual Arm Tingling

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outcome · POSTED

Overall Survival

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outcome · POSTED

Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event.

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outcome · POSTED

Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence

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outcome · POSTED

Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence

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outcome · POSTED

The Percentage of Technically Successful Sentinel Node Resections as Measured by the Proportion of Patients for Whom at Least One Sentinel Node is Identified.

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outcome · POSTED

Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Sentinel node resection immediately followed by axillary dissection
    intervention Names
    1. Procedure: conventional surgery
    label
    Arm I: Conventional axillary dissection
    type
    ACTIVE_COMPARATOR
  2. description
    Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.
    intervention Names
    1. Procedure: Sentinel node resection followed by node examination
    label
    Arm II: Sentinel node resection followed by node examination
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I: Conventional axillary dissection
    description
    Sentinel node resection immediately followed by axillary dissection.
    name
    conventional surgery
    type
    PROCEDURE
  2. arm Group Labels
    1. Arm II: Sentinel node resection followed by node examination
    description
    Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
    name
    Sentinel node resection followed by node examination
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
5611
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Morbidity - Number of Participants With Residual Shoulder Abduction Deficit
    time Frame
    Before and after surgery (within 30 days of randomization)
  2. description
    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
    measure
    Morbidity - Number of Participants With Residual Arm Volume Difference
    time Frame
    before and after surgery (within 30 days of randomization)
  3. description
    Morbidity as measured by residual arm numbness
    measure
    Morbidity - Number of Participants With Residual Arm Numbness
    time Frame
    before and after surgery (within 30 days of randomization)
  4. description
    Morbidity as measured by residual arm tingling
    measure
    Morbidity - Number of Participants With Residual Arm Tingling
    time Frame
    before and after surgery (within 30 days of randomization)
  5. description
    Measured at the time from randomization to any death to determine the percentage of patients alive at 8 years
    measure
    Overall Survival
    time Frame
    8 years
  6. description
    Measured at time from randomization to recurrence, second primary, or death to determine the percentage of patients disease free at 8 years.
    measure
    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
secondary Outcomes
  1. description
    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.
    measure
    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
  2. description
    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.
    measure
    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
  3. description
    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.
    measure
    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)
  4. description
    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.
    measure
    Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases.
    time Frame
    At time of surgery (within 30 days of randomization)
Full study description
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.
detailed Description
OBJECTIVES: * Compare the long term control of regional disease by sentinel node resection vs sentinel node resection followed by conventional axillary dissection in women with breast cancer who are clinically node negative and pathologically sentinel node negative. * Compare the effect of these two regimens on the overall and disease-free survival of these patients. * Compare the morbidity associated with these two regimens in these patients. * Compare the prognostic value of these two regimens in patients who are sentinel node negative or positive by pathology. * Determine whether a more detailed pathology investigation can identify a group of patients with a potentially increased risk of systemic recurrence who are node negative by pathology. * Determine the technical success rate of sentinel node dissection and the variability of technical success rate in a broad population of surgeons. * Determine the sensitivity of the sentinel node to determine the presence of nodal metastases in these patients. Objectives of quality of life questionnaire in sentinel node-negative patients: * Compare the severity of self-assessed symptoms and activity limitations of patients treated with these two regimens. * Compare the severity of self-assessed symptoms and activity limitations after breast cancer surgery in patients whose surgery was on the dominant side vs patients whose surgery was on the non-dominant side. * Compare the impact of arm edema, range of motion, and sensory neuropathy on self-assessed measures of daily functioning, symptoms, and overall quality of life of patients treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to the surgical treatment plan (lumpectomy vs mastectomy), age (49 and under vs 50 and over), and clinical tumor size (no greater than 2.0 cm vs 2.1-4.0 cm vs at least 4.1 cm). Patients are randomized to one of two surgery arms. All patients receive technetium (Tc 99m) sulfur colloid injected into normal breast tissue within 1 cm of the primary tumor or biopsy cavity and an intradermal injection of technetium (Tc 99m) sulfur colloid, approximately 0.5-8 hours before surgery. Patients also receive an injection of isosulfan blue dye around the tumor or biopsy cavity after a hot spot is identified with a gamma detector. If a hot spot is not identified, the blue dye is injected after a saline bolus injection. * Arm I: Patients undergo sentinel node resection immediately followed by conventional axillary dissection. * Arm II: Patients undergo sentinel node resection and an intraoperative examination of sentinel nodes. Patients with positive sentinel nodes undergo axillary dissection after sentinel node resection. Patients with cytologically negative sentinel nodes do not undergo axillary dissection. Patients with cytologically negative but histologically positive sentinel nodes return to surgery for axillary dissection. Patients with histologically positive sentinel nodes and those in whom the sentinel node is not identified undergo axillary dissection after sentinel node resection. Patients with pathologically positive, nonaxillary sentinel nodes undergo axillary dissection after sentinel node resection. Patients with evidence of tumor remaining after surgery undergo a total mastectomy. Quality of life is assessed at baseline, at weeks 1-3, and then every 6 months for 3 years or until recurrence. Patients are followed at 1 and 3 weeks, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 5,400 patients will be accrued for this study within 4 years.
Source references
references
  1. citation
    Land SR, Ritter MW, Costantino JP, Julian TB, Cronin WM, Haile SR, Wolmark N, Ganz PA. Compliance with patient-reported outcomes in multicenter clinical trials: methodologic and practical approaches. J Clin Oncol. 2007 Nov 10;25(32):5113-20. doi: 10.1200/JCO.2007.12.1749.
    pmid
    17991930
    type
    BACKGROUND
  2. citation
    Weaver DL, Le UP, Dupuis SL, Weaver KA, Harlow SP, Ashikaga T, Krag DN. Metastasis detection in sentinel lymph nodes: comparison of a limited widely spaced (NSABP protocol B-32) and a comprehensive narrowly spaced paraffin block sectioning strategy. Am J Surg Pathol. 2009 Nov;33(11):1583-9. doi: 10.1097/PAS.0b013e3181b274e7.
    pmid
    19730364
    type
    RESULT
  3. citation
    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.
    type
    RESULT
  4. citation
    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.
    type
    RESULT
  5. citation
    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.
    type
    RESULT
  6. citation
    Krag DN, Anderson SJ, Julian TB, Brown AM, Harlow SP, Ashikaga T, Weaver DL, Miller BJ, Jalovec LM, Frazier TG, Noyes RD, Robidoux A, Scarth HM, Mammolito DM, McCready DR, Mamounas EP, Costantino JP, Wolmark N; National Surgical Adjuvant Breast and Bowel Project. Technical outcomes of sentinel-lymph-node resection and conventional axillary-lymph-node dissection in patients with clinically node-negative breast cancer: results from the NSABP B-32 randomised phase III trial. Lancet Oncol. 2007 Oct;8(10):881-8. doi: 10.1016/S1470-2045(07)70278-4.
    pmid
    17851130
    type
    RESULT
  7. citation
    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.
    type
    RESULT
  8. citation
    Weaver DL, Krag DN, Manna EA, Ashikaga T, Waters BL, Harlow SP, Bauer KD, Julian TB. Detection of occult sentinel lymph node micrometastases by immunohistochemistry in breast cancer. An NSABP protocol B-32 quality assurance study. Cancer. 2006 Aug 15;107(4):661-7. doi: 10.1002/cncr.22074.
    pmid
    17024757
    type
    RESULT
  9. citation
    Harlow SP, Krag DN, Julian TB, Ashikaga T, Weaver DL, Feldman SA, Klimberg VS, Kusminsky R, Moffat FL Jr, Noyes RD, Beitsch PD. Prerandomization Surgical Training for the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-32 trial: a randomized phase III clinical trial to compare sentinel node resection to conventional axillary dissection in clinically node-negative breast cancer. Ann Surg. 2005 Jan;241(1):48-54. doi: 10.1097/01.sla.0000149429.39656.94.
    pmid
    15621990
    type
    RESULT
  10. citation
    Weaver DL, Ashikaga T, Krag DN, Skelly JM, Anderson SJ, Harlow SP, Julian TB, Mamounas EP, Wolmark N. Effect of occult metastases on survival in node-negative breast cancer. N Engl J Med. 2011 Feb 3;364(5):412-21. doi: 10.1056/NEJMoa1008108. Epub 2011 Jan 19.
    pmid
    21247310
    type
    DERIVED
  11. citation
    Krag DN, Anderson SJ, Julian TB, Brown AM, Harlow SP, Costantino JP, Ashikaga T, Weaver DL, Mamounas EP, Jalovec LM, Frazier TG, Noyes RD, Robidoux A, Scarth HM, Wolmark N. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol. 2010 Oct;11(10):927-33. doi: 10.1016/S1470-2045(10)70207-2.
    pmid
    20863759
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        rm function was also better in the SLN group.</li></ul></div></li><li>The National Surgical Adjuvant Breast and Bowel Project&#8217;s (<a href="/clinicaltrials/NCT00003830">NSABP-B-32</a> [NCT00003830]) multicenter, phase III trial randomly assigned women (N = 5,611) to undergo either SLN plus ALND or SLN resection alone. ALND
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        n the SLN group.</li></ul></div></li><li>The National Surgical Adjuvant Breast and Bowel Project&#8217;s (<a href="/clinicaltrials/NCT00003830">NSABP-B-32</a> [NCT00003830]) multicenter, phase III trial randomly assigned women (N = 5,611) to undergo either SLN plus ALND or SLN resection alone. ALND was only performed if the SLN
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      source update dates
      1. context
        Updated: April 25, 2025
        datetime
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        display
        April 25, 2025

    Preserved source evidence · Not medical advice