Phase 3
Completed N=5,611
Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
Source: ClinicalTrials.gov NCT00003830 ↗Enrolled (actual)
5,611
Serious AEs
0.3%
Results posted
Dec 2017
Primary outcomePrimary: Morbidity - Number of Participants With Residual Shoulder Abduction Deficit — 276; 200 Participants
◆ Published Evidence
Highly cited
1,079citations · ~57 / year
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.
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.
Linked Publications (5)
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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.
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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.
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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.
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Detection of occult sentinel lymph node micrometastases by immunohistochemistry in breast cancer. An NSABP protocol B-32 quality assurance study.
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Effect of occult metastases on survival in node-negative breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morbidity - Number of Participants With Residual Shoulder Abduction Deficit |
276; 200 | — |
| PRIMARY Morbidity - Number of Participants With Residual Arm Volume Difference |
314; 192 | — |
| PRIMARY Morbidity - Number of Participants With Residual Arm Numbness |
408; 103 | — |
| PRIMARY Morbidity - Number of Participants With Residual Arm Tingling |
175; 90 | — |
| PRIMARY Overall Survival |
91.8; 90.3 | — |
| 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. |
82.4; 81.5 | — |
| SECONDARY Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence |
92.5; 89.7 | — |
| 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. |
2672; 2707; 74; 83 | — |
| SECONDARY Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases. |
75; 691 | — |
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
Data sourced from ClinicalTrials.gov (NCT00003830) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.