Breast CancerPhase 3NCT00003830
Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
A Phase 3 study testing conventional surgery and Sentinel node resection followed by node examination in people with Breast Cancer, run by NSABP Foundation Inc at 78 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- conventional surgery and Sentinel node resection followed by node examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,611 participants
- Where
- 78 sitesin 3 countries
- Study dates
- May 1999to Feb 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
78 sites in 3 countries.
78 sites in 3 countries
United States68 sites
Akron City Hospital
Akron, Ohio, 44312
New York Oncology Hematology, P.C. - Albany Regional Cancer Center
Albany, New York, 12208
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
Franklin Square Hospital Center
Baltimore, Maryland, 21237
Eastern Maine Medical Center
Bangor, Maine, 04401
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, 02118
Vermont Cancer Center at University of Vermont
Burlington, Vermont, 05401-3498
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, 44710
Camcare Health
Charleston, West Virginia, 25304
MBCCOP-Cook County Hospital
Chicago, Illinois, 60612
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Jewish Hospital of Cincinnati, Incorporated
Cincinnati, Ohio, 45236
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0502
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
CCOP - Columbus
Columbus, Ohio, 43206
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001
Halifax Medical Center
Daytona Beach, Florida, 32114
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
Michigan State University
East Lansing, Michigan, 48824
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
Hartford Hospital
Hartford, Connecticut, 06102-5037
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, 46206-1367
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Kansas City
Kansas City, Missouri, 64131
CCOP - Dayton
Kettering, Ohio, 45429
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, 92354
University of Miami Sylvester Cancer Center
Miami, Florida, 33136
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, 70112
Tulane University Medical Center
New Orleans, Louisiana, 70112
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Virginia Oncology Associates - Newport News
Newport News, Virginia, 23606
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, 68114
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
CCOP - Columbia River Oncology Program
Portland, Oregon, 97213
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
CCOP - Beaumont
Royal Oaks, Michigan, 48073-6769
Sutter Breast Cancer Group
Sacramento, California, 95819-5156
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, 92120
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Puget Sound Oncology Consortium
Seattle, Washington, 98109
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Providence Cancer Institute at Providence Hospital
Southfield, Michigan, 48075-9975
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, 94305-5408
CCOP - Northwest
Tacoma, Washington, 98405-0986
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
CCOP - Wichita
Wichita, Kansas, 67214-3882
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
Canada9 sites
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1
Royal Victoria Hospital - Montreal
Montreal, Quebec, H3A 1A1
Jewish General Hospital - Montreal
Montreal, Quebec, H3T 1E2
St. Mary's Hospital Center
Montreal, Quebec, H3T 1M5
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1R 2J6
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- conventional surgery, Sentinel node resection followed by node examination
- Keywords
- stage I breast cancer, stage II breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
Sentinel node resection immediately followed by axillary dissection.
Sentinel node resection followed by node examinationProcedure or surgery
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Conventional axillary dissection | Active comparator | Sentinel node resection immediately followed by axillary dissection Receives: 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. Receives: Procedure: Sentinel node resection followed by node examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: before and after surgery (within 30 days of randomization)
Morbidity - Number of Participants With Residual Arm Numbness
Morbidity as measured by residual arm numbness
Measured: before and after surgery (within 30 days of randomization)
Morbidity - Number of Participants With Residual Arm Tingling
Morbidity as measured by residual arm tingling
Measured: 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
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
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.
Measured: At time of surgery (within 30 days of randomization)
Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases.
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.
Measured: At time of surgery (within 30 days of randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2003 (estimated)
- Study startMay 1999
- Primary completionSep 2010
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,611 participants (actual)
Sponsor and investigators
- Lead sponsor
- NSABP Foundation Inc
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Norman Wolmark, MD, Principal investigator, NSABP Foundation Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003830
- Sponsor's protocol ID
- NSABP B-32
- Other IDs
- U10CA012027, CDR0000066987
- Status last verified
- Nov 2017
- First submitted
- 1 Nov 1999
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 17991930Weaver 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.
PubMed 19730364Land 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; 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.
PubMed 17851130Julian 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. doi: 10.1002/cncr.22074.
PubMed 17024757Harlow 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.
PubMed 15621990Weaver 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.
PubMed 21247310Krag 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.
PubMed 20863759
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00003830
- Acronym / sponsor ID
- NSABP B-32
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,611 participants (actual)
- Lead sponsor
- NSABP Foundation IncResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1999
- Primary completion
- Sep 2010 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 28 Jan 2003 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I: Conventional axillary dissection | Active comparator | Procedure: conventional surgerySentinel node resection immediately followed by axillary dissection |
| Arm II: Sentinel node resection followed by node examination | Experimental | Procedure: Sentinel node resection followed by node examinationSentinel node resection followed by node examination then axillary dissection if positive sentinel node. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional surgerySentinel node resection immediately followed by axillary dissection. | Procedure or surgery | Arm I: Conventional axillary dissection |
| Sentinel node resection followed by node examinationSentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node. | Procedure or surgery | Arm II: Sentinel node resection followed by node examination |
Primary outcome
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.
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
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
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
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
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.
4 secondary outcomes
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
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
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)
Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases.
Time frame: At time of surgery (within 30 days of randomization)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17991930Land 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.
- Results publication: PubMed 19730364Weaver 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.
- Results publicationLand 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.
- Results publicationJulian 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.
- Results publicationJulian 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.
- Results publication: PubMed 17851130Krag 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.
- Results publicationJulian 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.
- Results publication: PubMed 17024757Weaver 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.
- Results publication: PubMed 15621990Harlow 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.
- Derived from this study: PubMed 21247310Weaver 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.
- Derived from this study: PubMed 20863759Krag 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman Wolmark, MD principal investigator
NSABP Foundation Inc
78 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing conventional surgery and Sentinel node resection followed by node examination in people with Breast Cancer, run by NSABP Foundation Inc at 78 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity - Number of Participants With Residual Shoulder Abduction Deficit (time frame: Before and after surgery (within 30 days of randomization)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003830, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.