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

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ClinicalTrials.gov Identifier: NCT01717131
Recruitment Status : Recruiting
First Posted : October 30, 2012
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Tracking Information
First Submitted Date  ICMJE October 19, 2012
First Posted Date  ICMJE October 30, 2012
Last Update Posted Date January 22, 2020
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date July 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2012)
Disease Free survival [ Time Frame: Time to relapse or progression up to 10 years ]
time from randomization to relapse or death.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2012)
  • 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.
  • Overall survival [ Time Frame: Time to death up to 10 years ]
    Time from randomization to date of death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Axillary Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node
Official Title  ICMJE 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
Brief Summary

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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Invasive Breast Cancer
Intervention  ICMJE
  • Procedure: Surgery for standard axillary node dissection
  • Other: No axillary lymph node dissection
    No surgery on axillary lymph node
Study Arms  ICMJE
  • Active Comparator: Surgery for standard axillary node dissection
    Standard axillary dissection
    Intervention: 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)
    Intervention: Other: No axillary lymph node dissection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2012)
3000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2028
Estimated Primary Completion Date July 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dominique GENRE, MD 33 (0)4 91 22 37 78 drci.up@ipc.unicancer.fr
Contact: Sandra COURNIER 33 (0)4 91 22 37 78 drci.up@ipc.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01717131
Other Study ID Numbers  ICMJE SERC / IPC 2012-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Paoli-Calmettes
Study Sponsor  ICMJE Institut Paoli-Calmettes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gilles HOUVENAEGHEL, MD, PHD Institut Paoli-Calmettes
PRS Account Institut Paoli-Calmettes
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP