Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

No surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial)

Surgery for standard axillary node dissection

No axillary lymph node dissection

Gilles HOUVENAEGHEL, MD, PHD

Data from cohorts, prospective studies and one randomized trial (ASCOG Z0011) support the hypothesis that omission of additional axillary dissection in case of positive sentinel node has a limited impact on overall survival and relapse free survival. However, these data are not sufficient enough to recommend, as a standard of care, to avoid axillary dissection in case of positive sentinel node. The ASCOG Z0011 trial has been closed before the end of inclusions and the predefined non inferiority margin was found to be too large (5% difference at 5 years for primary endpoint).

Prospective randomized trial is then urgently mandatory before omission of axillary node dissection becomes a usual practice without a sufficient scientific level of proof. Indeed, in several reviews, the rate of omission of axillary node dissection in case of micrometastasis increased (Bilimoria) despite any strong proof has been demonstrated.

The omission of axillary node dissection in case of positive sentinel node may have strong practical impacts on patients but also on medical and economical aspects: in avoiding a prolonged hospitalisation, secondary morbidities due to axillary dissection requiring secondary care and their costs, as well as costs for secondary axillary dissection (14 to 25% in case of positive sentinel node) and finally shortening surgery duration.

The main investigator propose a Non Inferiority Randomized Multicenter Phase III Trial of Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel Lymph Node in Invasive Breast Cancer

Axillary Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node

A Non Inferiority Randomized Multicenter Phase III Trial of Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel Lymph Node in Invasive Breast Cancer

time from randomization to relapse or death.

Estimate the incidence of axillary recurrence after surgery followed by axillary dissection or after surgery alone.

Institut Paoli-Calmettes

Symptoms and General Pathology

Neoplasm Micrometastasis

Neoplasm Metastasis

Neoplastic Processes

All Drugs and Chemicals

Estrogens

Progesterone

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

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

Axillary lymph node dissection

Viviana E. Galimberti

Umberto Veronesi, MD, Prof.

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.

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.

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

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

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.

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.

ETOP IBCSG Partners Foundation

Analysis population excludes 31 patients (17 in Axillary Dissection group/14 in No Axillary Dissection group) who did not receive the randomly-assigned treatment.

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

Axillary lymph node dissection: Axillary lymph node dissection

Axillary Dissection

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

No axillary lymph node dissection: Therapeutic conventional surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Axillary Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node	NCT01717131	Invasive Breast...	Surgery for sta... No axillary lym...	18 Years -	Institut Paoli-Calmettes
Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases	NCT00072293	Breast Cancer	Axillary lymph ... No axillary lym...	18 Years -	ETOP IBCSG Partners Foundation
Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases	NCT00072293	Breast Cancer	Axillary lymph ... No axillary lym...	18 Years -	ETOP IBCSG Partners Foundation

Spots Global Cancer Trial Database for no axillary lymph node dissection