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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

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

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

official web site of the sponsor 

Responsible Party:	Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:	NCT01717131 History of Changes
Other Study ID Numbers:	SERC / IPC 2012-001
First Posted:	October 30, 2012
Last Update Posted:	October 26, 2017
Last Verified:	October 2017

Keywords provided by Institut Paoli-Calmettes:

Invasive breast cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases