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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

Study Description
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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


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2012
Estimated Primary Completion Date : July 2028
Estimated Study Completion Date : July 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Disease Free survival [ Time Frame: Time to relapse or progression up to 10 years ]
    time from randomization to relapse or death.


Secondary Outcome Measures :
  1. 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.

  2. Overall survival [ Time Frame: Time to death up to 10 years ]
    Time from randomization to date of death


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717131


Contacts
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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

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

Publications of Results:

Other Publications:

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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01717131    
Other Study ID Numbers: SERC / IPC 2012-001
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Keywords provided by Institut Paoli-Calmettes:
Invasive breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases