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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:
NCT00003830
First received: November 1, 1999
Last updated: March 6, 2014
Last verified: March 2014
  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 3

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:


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
Study Completion Date: February 2014
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.

  Hide Detailed Description

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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)
Investigators
Principal Investigator: Norman Wolmark, MD NSABP Foundation, Inc.
  More Information

Additional Information:
Publications:
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.
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier: NCT00003830     History of Changes
Other Study ID Numbers: NSABP B-32, U10CA012027, CDR0000066987
Study First Received: November 1, 1999
Last Updated: March 6, 2014
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 August 18, 2014