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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Institut Paoli-Calmettes
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT01717131
First received: October 19, 2012
Last updated: September 6, 2013
Last verified: September 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Invasive Breast Cancer
 Procedure: Surgery for standard axillary node dissection
Other: No axillary lymph node dissection
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • Disease Free survival [ Time Frame: Time to relapse or progression up to 10 years ] [ Designated as safety issue: No ]
    time from randomization to relapse or death.


Secondary Outcome Measures:
  • axillary recurrence rate [ Time Frame: Time to local relapse up to 10 years ] [ Designated as safety issue: No ]
    Estimate the incidence of axillary recurrence after surgery followed by axillary dissection or after surgery alone.

  • Overall survival [ Time Frame: Time to death up to 10 years ] [ Designated as safety issue: No ]
    Time from randomization to date of death
Estimated Enrollment: 3000
Study Start Date: July 2012
Estimated Study Completion Date: July 2025
Estimated Primary Completion Date: July 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717131

Contacts
Contact: Dominique GENRE, MD 33 (0)4 91 22 37 78 bec@ipc.unicancer.fr
Contact: Sandra COURNIER 33 (0)4 91 22 37 78 bec@ipc.unicancer.fr

Locations
France
Gilles HOUVENAEGHEL, PHD Recruiting
Marseille, France, 13009
Contact: Gilles HOUVENAEGHEL, PhD    33(0)491223778    bec@ipc.unicancer.fr   
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Gilles HOUVENAEGHEL, MD, PHD Institut Paoli-Calmettes
  More Information

Additional Information:
official web site of the sponsor  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01717131     History of Changes
Other Study ID Numbers: SERC / IPC 2012-001
Study First Received: October 19, 2012
Last Updated: September 6, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Institut Paoli-Calmettes:
Invasive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on March 03, 2015