Completed

23-01A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node

What is being tested

Axillary lymph node dissection

+ No axillary lymph node dissection

Procedure

Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: December 2001

See protocol details

Summary

Principal SponsorETOP IBCSG Partners Foundation

Last updated: January 23, 2018

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2001

Actual date on which the first participant was enrolled.

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.

NCT00072293

Principal SponsorETOP IBCSG Partners Foundation

Last updated: January 23, 2018

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

931 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.

Group II

Experimental

Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 31 locations

Lismore Base Hospital

Lismore, AustraliaOpen Lismore Base Hospital in Google Maps

St Vincents Hospital

Lismore, Australia

Mater Hospital - North Sydney

North Sydney, Australia

Royal North Shore Hospital

St Leonards, Australia

Completed31 Study Centers