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

NCT01717131 | Active Not Recruiting

• 1 other identifier: SERC / IPC 2012-001
• Study Type: interventional
• Target: 2,228
• Locations: 1 country
• Sites: 1

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

Conditions

Invasive Breast Cancer

Keywords

Invasive breast cancer

Outcome Measures

Primary Outcomes (1)

• Disease Free survival

  time from randomization to relapse or death.

  Time to relapse or progression up to 10 years

Secondary Outcomes (2)

• axillary recurrence rate

  Time to local relapse up to 10 years

• Overall survival

  Time to death up to 10 years

Study Arms (2)

Surgery for standard axillary node dissection

ACTIVE COMPARATOR

Standard axillary dissection

Procedure: Surgery for standard axillary node dissection

No axillary lymph node dissection

EXPERIMENTAL

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

Interventions

Surgery for standard axillary node dissection PROCEDURE

Surgery for standard axillary node dissection

No axillary lymph node dissection OTHER

No surgery on axillary lymph node

No axillary lymph node dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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,
• Patients for whom conservative surgery with sentinel lymph node (SLN) technique is feasible from the start in terms of carcinologic,
• All patients with lymph node involvement (GS+), whatever the size of the metastasis (macro-metastasis, micro-metastasis, cellular cluster or isolated tumor cells),
• Patient affiliated to a social security system or benefiting from such a system,
• Signed consent to participate.

You may not qualify if:

• \- 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
• Patient deprived of liberty or under supervision of a guardian
• Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Gilles HOUVENAEGHEL, PHD

Marseille, 13009, France

Location

Related Publications (4)

• 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.

  PMID: 28898379 BACKGROUND

• 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.

  PMID: 25439688 BACKGROUND

• 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.

  PMID: 25135994 BACKGROUND

• 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.

  PMID: 30463611 RESULT

Related Links

• official web site of the sponsor

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Gilles HOUVENAEGHEL, MD, PHD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 30, 2012
• Study Start: July 19, 2012
• Primary Completion: September 1, 2021
• Study Completion (Estimated): September 1, 2031
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

FR (1)