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Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases (23-01)

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ClinicalTrials.gov Identifier: NCT00072293
Recruitment Status : Completed
First Posted : November 6, 2003
Results First Posted : May 18, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
ETOP IBCSG Partners Foundation

Study Description
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Brief Summary:

RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.

PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.


Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Axillary lymph node dissection Procedure: No axillary lymph node dissection Not Applicable

Detailed Description:

OBJECTIVES:

  • Compare disease-free survival of women with clinically node-negative breast cancer with sentinel lymph node micrometastases treated with surgical resection with or without axillary dissection.
  • Compare overall survival of patients treated with these regimens.
  • Assess sites of recurrence, particularly reappearance of disease in the undissected axilla.
  • Assess long-term surgical complications in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs postmenopausal), and preoperative sentinel node biopsy (yes vs no). Patients are followed every 4 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 931 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node
Study Start Date : December 2001
Actual Primary Completion Date : September 2012
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Axillary Dissection
Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
 Procedure: Axillary lymph node dissection
Axillary lymph node dissection
Experimental: No Axillary Dissection
Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.
 Procedure: No axillary lymph node dissection
Therapeutic conventional surgery


Outcome Measures
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Primary Outcome Measures :
  1. 5-year Disease-Free Survival [ Time Frame: 5-year estimate reported after a median follow-up of 60 months ]
    Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.


Secondary Outcome Measures :
  1. 5-year Overall Survival [ Time Frame: 5-year estimate reported after a median follow-up of 60 months ]
    Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death of any cause.

  2. Site of Recurrence [ Time Frame: Reported after a median follow-up of 60 months ]
    Site of recurrence of breast cancer


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma
  • Largest tumor lesion ≤ 5 cm

  • Palpable or nonpalpable breast lesion

    • Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions

  • Prior (preoperative) or planned (intraoperative) sentinel node biopsy required

    • At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension

  • No clinical evidence of distant metastases

    • No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:

      • Skeletal pain of unknown cause
      • Elevated alkaline phosphatase
      • Bone scan showing hot spots
  • No palpable axillary lymph node(s)
  • No Paget's disease without invasive cancer

  • Hormone receptor status:

    • Estrogen receptor and progesterone receptor known

PATIENT CHARACTERISTICS:

Age

  • Any age

Sex

  • Female

Menopausal status

  • Any status

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • See Disease Characteristics

Renal

  • Not specified

Other

  • Not pregnant or nursing

  • No other prior or concurrent malignancy except the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • Adequately treated carcinoma in situ of the cervix
    • Adequately treated in situ melanoma
    • Contralateral or ipsilateral carcinoma in situ of the breast
  • No psychiatric, addictive, or other disorder that may compromise ability to give informed consent
  • Geographically accessible for follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics

Other

  • No prior systemic therapy for breast cancer
  • More than 1 year since prior chemopreventive agent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072293


Locations
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Sponsors and Collaborators
ETOP IBCSG Partners Foundation
Investigators
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Study Chair: Viviana E. Galimberti European Institute of Oncology
Study Chair: Umberto Veronesi, MD, Prof. European Institute of Oncology
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ETOP IBCSG Partners Foundation
ClinicalTrials.gov Identifier: NCT00072293    
Other Study ID Numbers: CDR0000339581
IBCSG 23-01 ( Other Identifier: IBCSG )
First Posted: November 6, 2003    Key Record Dates
Results First Posted: May 18, 2016
Last Update Posted: January 23, 2018
Last Verified: December 2017
Keywords provided by ETOP IBCSG Partners Foundation:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
estrogen receptor-negative breast cancer
 estrogen receptor-positive breast cancer
progesterone receptor-negative breast cancer
progesterone receptor-positive breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Micrometastasis
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes