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

January 9, 2024 updated by: Institut Paoli-Calmettes

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13009
        • Gilles HOUVENAEGHEL, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. - Patient aged 18 years and above,
  2. - Patient with invasive breast cancer histologically proven or cytologically proven by fine needle biopsy,
  3. - Patient with a unifocal tumor T0 - T1 - T2 up to 5 cm (clinical or in imagery), without previous therapy (neoadjuvant chemotherapy or hormone therapy),
  4. - Patient with clinical N0 status,
  5. - Absence of clinically detectable metastases known,

6- Patients for whom conservative surgery with sentinel lymph node (SLN) technique is feasible from the start in terms of carcinologic,

7 -All patients with lymph node involvement (GS+), whatever the size of the metastasis (macro-metastasis, micro-metastasis, cellular cluster or isolated tumor cells),

8 - Patient affiliated to a social security system or benefiting from such a system,

9 - Signed consent to participate.

Exclusion Criteria:

  1. - Tumor of more than 5 cm
  2. - Indication of neoadjuvant therapy by chemotherapy or hormone therapy
  3. - History of breast cancer (ipsilateral, ie recurrence, or contralateral breast)
  4. - History of any other invasive cancer other than a past cutaneous cancer correctly treated
  5. - Initial metastatic disease known
  6. - Presence of clinical axillary adenopathy
  7. - Contra-indication to surgical excision
  8. - Contra-indication to the SLN technique
  9. - Pregnant women, of child-bearing potential, or lactating women

10- Patient deprived of liberty or under supervision of a guardian

11- Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Surgery for standard axillary node dissection
Standard axillary dissection
Procedure: Surgery for standard axillary node dissection
Experimental: No axillary lymph node dissection
No surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial)
Other: No axillary lymph node dissection
No surgery on axillary lymph node

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free survival
Time Frame: Time to relapse or progression up to 10 years
time from randomization to relapse or death.
Time to relapse or progression up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
axillary recurrence rate
Time Frame: Time to local relapse up to 10 years
Estimate the incidence of axillary recurrence after surgery followed by axillary dissection or after surgery alone.
Time to local relapse up to 10 years
Overall survival
Time Frame: Time to death up to 10 years
Time from randomization to date of death
Time to death up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Gilles HOUVENAEGHEL, MD, PHD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2012

Primary Completion (Actual)

September 1, 2021

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

October 19, 2012

First Submitted That Met QC Criteria

October 26, 2012

First Posted (Estimated)

October 30, 2012

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SERC / IPC 2012-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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