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

Primary Purpose

Invasive Breast Cancer

Status

Recruiting

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Surgery for standard axillary node dissection

No axillary lymph node dissection

About this trial

This is an interventional treatment trial for Invasive Breast Cancer focused on measuring Invasive breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

- Patient aged 18 years and above,
- Patient with invasive breast cancer histologically proven or cytologically proven by fine needle biopsy,
- Patient with a unifocal tumor T0 - T1 - T2 up to 5 cm (clinical or in imagery), without previous therapy (neoadjuvant chemotherapy or hormone therapy),
- Patient with clinical N0 status,
- 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:

- Tumor of more than 5 cm
- Indication of neoadjuvant therapy by chemotherapy or hormone therapy
- History of breast cancer (ipsilateral, ie recurrence, or contralateral breast)
- History of any other invasive cancer other than a past cutaneous cancer correctly treated
- Initial metastatic disease known
- Presence of clinical axillary adenopathy
- Contra-indication to surgical excision
- Contra-indication to the SLN technique
- 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.

Sites / Locations

Gilles HOUVENAEGHEL, PHDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Surgery for standard axillary node dissection

No axillary lymph node dissection

Arm Description

Standard axillary dissection

No surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial)

Outcomes

Primary Outcome Measures

Disease Free survival

time from randomization to relapse or death.

Secondary Outcome Measures

axillary recurrence rate

Estimate the incidence of axillary recurrence after surgery followed by axillary dissection or after surgery alone.

Overall survival

Time from randomization to date of death

Full Information

NCT ID

NCT01717131

First Posted

October 19, 2012

Last Updated

January 17, 2020

Sponsor

Institut Paoli-Calmettes

1. Study Identification

Unique Protocol Identification Number

NCT01717131

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Recruiting

Study Start Date

July 2012 (undefined)

Primary Completion Date

July 2028 (Anticipated)

Study Completion Date

July 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Invasive Breast Cancer

Keywords

Invasive breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgery for standard axillary node dissection

Arm Type

Active Comparator

Arm Description

Standard axillary dissection

Arm Title

No axillary lymph node dissection

Arm Type

Experimental

Arm Description

No surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial)

Intervention Type

Procedure

Intervention Name(s)

Surgery for standard axillary node dissection

Intervention Type

Other

Intervention Name(s)

No axillary lymph node dissection

Intervention Description

No surgery on axillary lymph node

Primary Outcome Measure Information:

Title

Disease Free survival

Description

time from randomization to relapse or death.

Time Frame

Time to relapse or progression up to 10 years

Secondary Outcome Measure Information:

Title

axillary recurrence rate

Description

Estimate the incidence of axillary recurrence after surgery followed by axillary dissection or after surgery alone.

Time Frame

Time to local relapse up to 10 years

Title

Overall survival

Description

Time from randomization to date of death

Time Frame

Time to death up to 10 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Patient aged 18 years and above, - Patient with invasive breast cancer histologically proven or cytologically proven by fine needle biopsy, - Patient with a unifocal tumor T0 - T1 - T2 up to 5 cm (clinical or in imagery), without previous therapy (neoadjuvant chemotherapy or hormone therapy), - Patient with clinical N0 status, - 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: - Tumor of more than 5 cm - Indication of neoadjuvant therapy by chemotherapy or hormone therapy - History of breast cancer (ipsilateral, ie recurrence, or contralateral breast) - History of any other invasive cancer other than a past cutaneous cancer correctly treated - Initial metastatic disease known - Presence of clinical axillary adenopathy - Contra-indication to surgical excision - Contra-indication to the SLN technique - 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dominique GENRE, MD

Phone

33 (0)4 91 22 37 78

drci.up@ipc.unicancer.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Sandra COURNIER

Phone

33 (0)4 91 22 37 78

drci.up@ipc.unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilles HOUVENAEGHEL, MD, PHD

Organizational Affiliation

Institut Paoli-Calmettes

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gilles HOUVENAEGHEL, PHD

City

Marseille

ZIP/Postal Code

13009

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gilles HOUVENAEGHEL, PhD

Phone

33(0)491223778

drci.up@ipc.unicancer.fr

12. IPD Sharing Statement

Citations:

PubMed Identifier

28898379

Citation

Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.

Results Reference

background

PubMed Identifier

25439688

Citation

Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJ, Mansel RE, Cataliotti L, Westenberg AH, Klinkenbijl JH, Orzalesi L, Bouma WH, van der Mijle HC, Nieuwenhuijzen GA, Veltkamp SC, Slaets L, Duez NJ, de Graaf PW, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JW, Belkacemi Y, Petignat P, Schinagl DA, Coens C, Messina CG, Bogaerts J, Rutgers EJ. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol. 2014 Nov;15(12):1303-10. doi: 10.1016/S1470-2045(14)70460-7. Epub 2014 Oct 15.

Results Reference

background

PubMed Identifier

25135994

Citation

Jagsi R, Chadha M, Moni J, Ballman K, Laurie F, Buchholz TA, Giuliano A, Haffty BG. Radiation field design in the ACOSOG Z0011 (Alliance) Trial. J Clin Oncol. 2014 Nov 10;32(32):3600-6. doi: 10.1200/JCO.2014.56.5838. Epub 2014 Aug 18.

Results Reference

background

PubMed Identifier

30463611

Citation

Houvenaeghel G, Cohen M, Raro P, De Troyer J, de Lara CT, Gimbergues P, Gauthier T, Faure-Virelizier C, Vaini-Cowen V, Lantheaume S, Regis C, Darai E, Ceccato V, D'Halluin G, Del Piano F, Villet R, Jouve E, Beedassy B, Theret P, Gabelle P, Zinzindohoue C, Opinel P, Marsollier-Ferrer C, Dhainaut-Speyer C, Colombo PE, Lambaudie E, Tallet A, Boher JM; Others investigators (SERC trial group). Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node. BMC Cancer. 2018 Nov 21;18(1):1153. doi: 10.1186/s12885-018-5053-7.

Results Reference

result

Links:

URL

http://www.institutpaolicalmettes.fr

Description

official web site of the sponsor

Learn more about this trial

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

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