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Home > "S" Clinical Trials Conditions > Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer

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



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

For Condition: stage 1 breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): National Surgical Adjuvant Breast and Bowel Project (NSABP) , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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: - Not specified 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DavidKrag,  Study Chair,  Vermont Cancer Center at University of Vermont

Tulane University Medical Center *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Contact  Person 504-585-6450

Jewish Hospital of Cincinnati, Incorporated *Recruiting*
Cincinnati,  Ohio,  45236
United States
Recruiting Contact  Person 513-686-5434 ext. 5434

MBCCOP - Massey Cancer Center *Recruiting*
Richmond,  Virginia,  23298-0037
United States
Recruiting Contact  Person 804-628-1893

Sarasota Memorial Hospital *Recruiting*
Sarasota,  Florida,  34239
United States
Recruiting Contact  Person 941-363-5713

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha,  Nebraska,  68114
United States
Recruiting Contact  Person 402-354-8237

Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem,  North Carolina,  27157-1082
United States
Recruiting Contact  Person 336-716-6240

Akron City Hospital *Recruiting*
Akron,  Ohio,  44312
United States
Recruiting Contact  Person 330-375-4221

CCOP - Dayton *Recruiting*
Kettering,  Ohio,  45429
United States
Recruiting Contact  Person 937-395-8678

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego *Recruiting*
San Diego,  California,  92120
United States
Recruiting Contact  Person 619-528-5896

CCOP - Columbia River Oncology Program *Recruiting*
Portland,  Oregon,  97213
United States
Recruiting Contact  Person 503-216-6262

Virginia Oncology Associates - Newport News *Recruiting*
Newport News,  Virginia,  23606
United States
Recruiting Contact  Person 757-873-9834

CCOP - MainLine Health *Recruiting*
Wynnewood,  Pennsylvania,  19096
United States
Recruiting Contact  Person 610-645-2680

MBCCOP-Cook County Hospital *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Contact  Person 312-864-5204

Eastern Maine Medical Center *Recruiting*
Bangor,  Maine,  04401
United States
Recruiting Contact  Person 207-973-4274

Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford,  California,  94305-5408
United States
Recruiting Contact  Person 650-724-1953

Cancer Institute of New Jersey *Recruiting*
New Brunswick,  New Jersey,  08903
United States
Recruiting Contact  Person 732-235-9659

CCOP - Columbus *Recruiting*
Columbus,  Ohio,  43206
United States
Recruiting Contact  Person 614-488-2118

Cancer Research Center of Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Contact  Person 808-586-2979

Centre Hospitalier de l'Universite de Montreal *Recruiting*
Montreal,  Quebec,  H2L-4M1
Canada
Recruiting Contact  Person 514-890-8000 ext. 15535

CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor,  Michigan,  48106
United States
Recruiting Contact  Person 734-712-5947

CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem,  North Carolina,  27104-4241
United States
Recruiting Contact  Person 336-777-3094

Franklin Square Hospital Center *Recruiting*
Baltimore,  Maryland,  21237
United States
Recruiting Contact  Person 443-777-7962

Halifax Medical Center *Recruiting*
Daytona Beach,  Florida,  32114
United States
Recruiting Contact  Person 386-254-4211

CCOP - Montana Cancer Consortium *Recruiting*
Billings,  Montana,  59101
United States
Recruiting Contact  Person 406-259-2245

CCOP - Kalamazoo *Recruiting*
Kalamazoo,  Michigan,  49007-3731
United States
Recruiting Contact  Person 269-373-7458

Newark Beth Israel Medical Center *Recruiting*
Newark,  New Jersey,  07112
United States
Recruiting Contact  Person 973-926-3136

Allegheny General Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15212-4772
United States
Recruiting Contact  Person 412-359-6526

Utah Valley Regional Medical Center - Provo *Recruiting*
Provo,  Utah,  84604
United States
Recruiting Contact  Person 801-321-1236

Royal Victoria Hospital - Montreal *Recruiting*
Montreal,  Quebec,  H3A 1A1
Canada
Recruiting Contact  Person 514-843-1572

Jewish General Hospital - Montreal *Recruiting*
Montreal,  Quebec,  H3T 1E2
Canada
Recruiting Contact  Person 514-340-8222, Ext. 5526

University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester,  Massachusetts,  01655
United States
Recruiting Contact  Person 508-856-3215

Geisinger Medical Center *Recruiting*
Danville,  Pennsylvania,  17822-2001
United States
Recruiting Contact  Person 570-271-6362

Hartford Hospital *Recruiting*
Hartford,  Connecticut,  06102-5037
United States
Recruiting Contact  Person 860-545-5363

Puget Sound Oncology Consortium *Recruiting*
Seattle,  Washington,  98109
United States
Recruiting Contact  Person 206-667-4692

CCOP - Merit Care Hospital *Recruiting*
Fargo,  North Dakota,  58122
United States
Recruiting Contact  Person 701-234-6298

CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines,  Iowa,  50309-1016
United States
Recruiting Contact  Person 515-244-7586

Creticos Cancer Center at Advocate Illinois Masonic Medical Center *Recruiting*
Chicago,  Illinois,  60657
United States
Recruiting Contact  Person 773-296-5360

Huntsman Cancer Institute *Recruiting*
Salt Lake City,  Utah,  84112
United States
Recruiting Contact  Person 801-585-5162

MBCCOP - Gulf Coast *Recruiting*
Mobile,  Alabama,  36688
United States
Recruiting Contact  Person 251-435-3941

MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C.,  District of Columbia,  20060
United States
Recruiting Contact  Person 202-806-9122

CCOP - Mount Sinai Medical Center *Recruiting*
Miami,  Florida,  33140
United States
Recruiting Contact  Person 305-674-2625

New York Oncology Hematology, P.C. - Albany Regional Cancer Center *Recruiting*
Albany,  New York,  12208
United States
Recruiting Contact  Person 518-489-2607

Baptist Regional Cancer Institute - Jacksonville *Recruiting*
Jacksonville,  Florida,  32207
United States
Recruiting Contact  Person 904-202-7069

Saint John Regional Hospital *Recruiting*
Saint John,  New Brunswick,  E2L 4L2
Canada
Recruiting Contact  Person 506-648-7758

Michigan State University *Recruiting*
East Lansing,  Michigan,  48824
United States
Recruiting Contact  Person 517-334-2715

CCOP - Wichita *Recruiting*
Wichita,  Kansas,  67214-3882
United States
Recruiting Contact  Person 316-268-5696

St. Mary's Hospital Center *Recruiting*
Montreal,  Quebec,  H3T 1M5
Canada
Recruiting Contact  Person 514-345-3511, Ext. 3378

Aultman Hospital Cancer Center at Aultman Health Foundation *Recruiting*
Canton,  Ohio,  44710
United States
Recruiting Contact  Person 330-363-3277

Sutter Breast Cancer Group *Recruiting*
Sacramento,  California,  95819-5156
United States
Recruiting Contact  Person 916-453-5800

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia,  Pennsylvania,  19107-5541
United States
Recruiting Contact  Person 215-955-1562

University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio,  Texas,  78284-7811
United States
Recruiting Contact  Person 210-567-5751

City of Hope Comprehensive Cancer Center *Recruiting*
Duarte,  California,  91010-3000
United States
Recruiting Contact  Person 626-359-8111, Ext. 62340

MBCCOP - San Juan *Recruiting*
San Juan,  ,  00927-5800
Puerto Rico
Recruiting Contact  Person 787-763-1296

CCOP - Upstate Carolina *Recruiting*
Spartanburg,  South Carolina,  29303
United States
Recruiting Contact  Person 864-560-6812

Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit,  Michigan,  48202
United States
Recruiting Contact  Person 313-916-7277

Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto,  Ontario,  M4N 3M5
Canada
Recruiting Contact  Person 416-480-6063

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Contact  Person 816-823-0555

CCOP - Illinois Oncology Research Association *Recruiting*
Peoria,  Illinois,  61602
United States
Recruiting Contact  Person 309-636-3605

Loma Linda University Cancer Institute at Loma Linda University Medical Center *Recruiting*
Loma Linda,  California,  92354
United States
Recruiting Contact  Person 909-558-3375 ext. 33377

Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Contact  Person 504-568-3307

Vermont Cancer Center at University of Vermont *Recruiting*
Burlington,  Vermont,  05401-3498
United States
Recruiting Contact  Person 802-656-2278

Methodist Cancer Center at Methodist Hospital *Recruiting*
Indianapolis,  Indiana,  46206-1367
United States
Recruiting Contact  Person 317-929-6597

CCOP - Beaumont *Recruiting*
Royal Oak,  Michigan,  48073-6769
United States
Recruiting Contact  Person 248-551-6927

CCOP - Grand Rapids *Recruiting*
Grand Rapids,  Michigan,  49503
United States
Recruiting Contact  Person 616-391-1230

University of Miami Sylvester Cancer Center *Recruiting*
Miami,  Florida,  33136
United States
Recruiting Contact  Person 305-243-3382

Cancer Research Center at Boston Medical Center *Recruiting*
Boston,  Massachusetts,  02118
United States
Recruiting Contact  Person 617-638-8434

Reading Hospital and Medical Center *Recruiting*
Reading,  Pennsylvania,  19612-6052
United States
Recruiting Contact  Person 610-988-8193

Camcare Health *Recruiting*
Charleston,  West Virginia,  25304
United States
Recruiting Contact  Person 304-388-9936

University of Arkansas for Medical Sciences *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Contact  Person 501-686-8274

Centre Hospitalier Universitaire de Quebec *Recruiting*
Quebec City,  Quebec,  G1R 2J6
Canada
Recruiting Contact  Person 418-682-8032

Ireland Cancer Center *Recruiting*
Cleveland,  Ohio,  44106-5065
United States
Recruiting Contact  Person 216-844-4724

CCOP - Northwest *Recruiting*
Tacoma,  Washington,  98405-0986
United States
Recruiting Contact  Person 253-403-1461

Providence Cancer Institute at Providence Hospital *Recruiting*
Southfield,  Michigan,  48075-9975
United States
Recruiting Contact  Person 248-424-5337

Princess Margaret Hospital *Recruiting*
Toronto,  Ontario,  M5G 2M9
Canada
Recruiting Contact  Person 416-976-4501 ext. 5836

CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend,  Indiana,  46601
United States
Recruiting Contact  Person 574-284-7977

Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati,  Ohio,  45267-0502
United States
Recruiting Contact  Person 513-584-0207

Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee,  Wisconsin,  53226
United States
Recruiting Contact  Person 414-805-5831

St. Michael's Hospital - Toronto *Recruiting*
Toronto,  Ontario,  M5B 1W8
Canada
Recruiting Contact  Person 416-864-5354


Additional Information:
Study ID Numbers:
  CDR0000066987;  NSABP-B-32
Study Start Date: 
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003830

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

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