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

NCT00003830 | Completed Phase 3 Results DMC

• 3 other identifiers: NSABP B-32U10CA012027CDR0000066987
• Study Type: interventional
• Target: 5,611
• Locations: 3 countries
• Sites: 78

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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer

Outcome Measures

Primary Outcomes (6)

• Morbidity - Number of Participants With Residual Shoulder Abduction Deficit

  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.

  Before and after surgery (within 30 days of randomization)

• Morbidity - Number of Participants With Residual Arm Volume Difference

  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

  before and after surgery (within 30 days of randomization)

• Morbidity - Number of Participants With Residual Arm Numbness

  Morbidity as measured by residual arm numbness

  before and after surgery (within 30 days of randomization)

• Morbidity - Number of Participants With Residual Arm Tingling

  Morbidity as measured by residual arm tingling

  before and after surgery (within 30 days of randomization)

• Overall Survival

  Measured at the time from randomization to any death to determine the percentage of patients alive at 8 years

  8 years

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

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

  8 years

Secondary Outcomes (4)

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

  From the time of randomization until 5 years

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

  From the time of randomization until 5 years

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

  At time of surgery (within 30 days of randomization)

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

  At time of surgery (within 30 days of randomization)

Study Arms (2)

Arm I: Conventional axillary dissection

ACTIVE COMPARATOR

Sentinel node resection immediately followed by axillary dissection

Procedure: conventional surgery

Arm II: Sentinel node resection followed by node examination

EXPERIMENTAL

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

Procedure: Sentinel node resection followed by node examination

Interventions

conventional surgery PROCEDURE

Sentinel node resection immediately followed by axillary dissection.

Arm I: Conventional axillary dissection

Sentinel node resection followed by node examination PROCEDURE

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

Arm II: Sentinel node resection followed by node examination

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NSABP Foundation Inc: lead
• National Cancer Institute (NCI): collaborator

Study Sites (78)

MBCCOP - Gulf Coast

Mobile, Alabama, 36688, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Sutter Breast Cancer Group

Sacramento, California, 95819-5156, United States

Location

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

San Diego, California, 92120, United States

Location

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

MBCCOP - Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

Halifax Medical Center

Daytona Beach, Florida, 32114, United States

Location

Baptist Regional Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

University of Miami Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

MBCCOP-Cook County Hospital

Chicago, Illinois, 60612, United States

Location

Creticos Cancer Center at Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

Methodist Cancer Center at Methodist Hospital

Indianapolis, Indiana, 46206-1367, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Massachusetts Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Beaumont

Royal Oaks, Michigan, 48073-6769, United States

Location

Providence Cancer Institute at Providence Hospital

Southfield, Michigan, 48075-9975, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

Omaha, Nebraska, 68114, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

New York Oncology Hematology, P.C. - Albany Regional Cancer Center

Albany, New York, 12208, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Akron City Hospital

Akron, Ohio, 44312, United States

Location

Aultman Hospital Cancer Center at Aultman Health Foundation

Canton, Ohio, 44710, United States

Location

Jewish Hospital of Cincinnati, Incorporated

Cincinnati, Ohio, 45236, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0502, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

CCOP - Dayton

Kettering, Ohio, 45429, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97213, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05401-3498, United States

Location

Virginia Oncology Associates - Newport News

Newport News, Virginia, 23606, United States

Location

MBCCOP - Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Puget Sound Oncology Consortium

Seattle, Washington, 98109, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Camcare Health

Charleston, West Virginia, 25304, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital - Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L-4M1, Canada

Location

Royal Victoria Hospital - Montreal

Montreal, Quebec, H3A 1A1, Canada

Location

Jewish General Hospital - Montreal

Montreal, Quebec, H3T 1E2, Canada

Location

St. Mary's Hospital Center

Montreal, Quebec, H3T 1M5, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

MBCCOP - San Juan

San Juan, 00927-5800, Puerto Rico

Location

Related Publications (11)

• 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 BACKGROUND

• 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 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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 RESULT

• 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.

  RESULT

• 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 RESULT

• 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 RESULT

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Director, Department of Regulatory Affairs
• Organization: NSABP Foundation, Inc

regulatory@nsabp.org

412-339-5300

Study Officials

• Norman Wolmark, MD

  NSABP Foundation Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 28, 2003
• Study Start: May 1, 1999
• Primary Completion: September 1, 2010
• Study Completion: February 1, 2014
• Last Updated: December 13, 2017
• Results First Posted: December 13, 2017

Record last verified: 2017-11

Locations

PR (1); US (68); CA (9)