CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 931 enrolled
Drug / intervention
Axillary lymph node dissection +1 moreprocedure
Likely dose
Not stated in record
Key inclusion· 8
  • Unicentric and unifocal breast carcinoma with clinical, mammographic, ultrasonographic, or pathologic diagnosis
  • Largest tumor lesion ≤5 cm
  • Prior (preoperative) or planned (intraoperative) sentinel node biopsy required
  • At least 1 micrometastatic sentinel lymph node (≤2 mm) with no extracapsular extension
Key exclusion· 7
  • Paget's disease without invasive cancer
  • Suspicious manifestations of metastases that cannot be ruled out by imaging (skeletal pain of unknown cause, elevated alkaline phosphatase, bone scan hot spots)
  • Palpable axillary lymph nodes
  • Prior systemic therapy for breast cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00072293
NCT00072293N/ACompleted

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

ETOP IBCSG Partners Foundation·interventional·Posted Nov 6, 2003·Updated Jan 23, 2018

In Brief

A clinical study evaluating Axillary lymph node dissection and No axillary lymph node dissection for Breast Cancer. Completed, enrolled 931 participants across 31 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Belgium, Brazil, Denmark, France, Italy, New Zealand, Peru, Slovenia, Switzerland
Collaborators--

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2003
Enrollment StartDec 1, 2001
Primary CompletionSep 1, 2012
Study CompletionMar 31, 2017
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 22.7 years ago

Interventions

Axillary lymph node dissectionprocedure

Axillary lymph node dissection

No axillary lymph node dissectionprocedure

Therapeutic conventional surgery