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A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Morbidity as measured by arm edema, sensory neuropathy, and arm function - mobility

Outcome Time Frame:

Before and after surgery

Safety Issue:

No

Principal Investigator

Norman Wolmark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NSABP Foundation, Inc.

Authority:

United States: Federal Government

Study ID:

NSABP B-32

NCT ID:

NCT00003830

Start Date:

May 1999

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Ireland Cancer CenterCleveland, Ohio  44106-5065
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Methodist Cancer Center at Methodist HospitalIndianapolis, Indiana  46202
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - Merit Care HospitalFargo, North Dakota  58122
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Halifax Medical CenterDaytona Beach, Florida  32114
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Newark Beth Israel Medical CenterNewark, New Jersey  07112
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Baptist Regional Cancer Institute - JacksonvilleJacksonville, Florida  32207
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
MBCCOP - Gulf CoastMobile, Alabama  36688
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
CCOP - NorthwestTacoma, Washington  98405-0986
Puget Sound Oncology ConsortiumSeattle, Washington  98109
Hartford HospitalHartford, Connecticut  06102-5037
Sarasota Memorial HospitalSarasota, Florida  34239
MBCCOP-Cook County HospitalChicago, Illinois  60612
Eastern Maine Medical CenterBangor, Maine  04401
Franklin Square Hospital CenterBaltimore, Maryland  21237
Michigan State UniversityEast Lansing, Michigan  48824
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Virginia Oncology Associates - Newport NewsNewport News, Virginia  23606
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San DiegoSan Diego, California  92120
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
City of Hope Comprehensive Cancer CenterDuarte, California  91010
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - OmahaOmaha, Nebraska  68114-4199
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Creticos Cancer Center at Advocate Illinois Masonic Medical CenterChicago, Illinois  60657
Providence Cancer Institute at Providence HospitalSouthfield, Michigan  48075
University of Miami Sylvester Cancer CenterMiami, Florida  33136
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New OrleansNew Orleans, Louisiana  70112
Tulane University Medical CenterNew Orleans, Louisiana  70112
New York Oncology Hematology, P.C. - Albany Regional Cancer CenterAlbany, New York  12208
Jewish Hospital of Cincinnati, IncorporatedCincinnati, Ohio  45236
Sutter Breast Cancer GroupSacramento, California  95819-5156
Camcare HealthCharleston, West Virginia  25304