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

Sponsor:	National Surgical Adjuvant Breast and Bowel Project (NSABP)
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:	NCT00003830

Purpose

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	Intervention	Phase
Breast Cancer	Procedure: conventional surgery Procedure: Sentinel node resection followed by node examination	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

Primary Outcome Measures:

Morbidity as measured by arm edema, sensory neuropathy, and arm function - mobility [ Time Frame: Before and after surgery ] [ Designated as safety issue: No ]
Overall Survival as measured by death from any cause. [ Time Frame: Time from surgery to death from any cause ] [ Designated as safety issue: No ]
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: Time from surgery to recurrence, second primary, or death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prognostic value of pathology status of sentinel nodes and nodes obtained from axillary dissection [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
Pathology investigation of sentinel nodes [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Sensitivity of the sentinel node to determine presence of nodal metastases. [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]

Enrollment:	5611
Study Start Date:	May 1999
Estimated Study Completion Date:	March 2013
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003830

Show 78 Study Locations

Sponsors and Collaborators

National Surgical Adjuvant Breast and Bowel Project (NSABP)

National Cancer Institute (NCI)

Investigators

Study Chair:

David N. Krag, MD, FACS

University of Vermont

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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 Aug 28; [Epub ahead of print]

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.

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; for the National Surgical Adjuvant Breast and Bowel Project (NSABP). 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.

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.

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.

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.

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. Review.

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

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. Epub 2011 Jan 19.

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.

Responsible Party:	Norman Wolmark, MD, NSABP Foundation, Inc.
ClinicalTrials.gov Identifier:	NCT00003830 History of Changes
Other Study ID Numbers:	NSABP B-32, U10CA012027, CDR0000066987
Study First Received:	November 1, 1999
Last Updated:	April 18, 2011
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 13, 2012