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Invasive Breast CancerNCT01717131

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

A study testing Surgery for standard axillary node dissection and No axillary lymph node dissection in people with Invasive Breast Cancer, run by Institut Paoli-Calmettes at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Invasive Breast Cancer
What is being tested?
Surgery for standard axillary node dissection and No axillary lymph node dissection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,228 participants
Where
1 siteFrance
Study dates
19 Jul 2012to Sep 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - 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,
Show all 9Show fewer
  • 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.

Who cannot join

  • - 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
Show all 11Show fewer
  • - 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gilles HOUVENAEGHEL, PHD

    Marseille, 13009

Other trials in France

About this study

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

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.

Read more

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

Being tested
Surgery for standard axillary node dissection, No axillary lymph node dissection
Keywords
Invasive breast cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgery for standard axillary node dissectionProcedure or surgery

  • No axillary lymph node dissectionOther

    No surgery on axillary lymph node

Study groups in NCT01717131
Study groupRoleWhat they receive
Surgery for standard axillary node dissectionActive comparatorStandard axillary dissection
Receives: Procedure: Surgery for standard axillary node dissection
No axillary lymph node dissectionExperimentalNo surgery of axillary lymph node In this study, the absence of surgery is the experimental arm (non-inferiority trial)
Receives: Other: No axillary lymph node dissection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Free survival

    time from randomization to relapse or death.

    Measured: Time to relapse or progression up to 10 years

Secondary outcomes (2)

  1. axillary recurrence rate

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

    Measured: Time to local relapse up to 10 years

  2. Overall survival

    Time from randomization to date of death

    Measured: Time to death up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2012 (estimated)
  2. Study start19 Jul 2012
  3. Primary completionSep 2021
  4. Study completionSep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01717131
Sponsor's protocol ID
SERC / IPC 2012-001
Status last verified
Jan 2024
First submitted
19 Oct 2012
Last updated
11 Jan 2024
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28898379

  • 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.

    PubMed 25439688

  • 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.

    PubMed 25135994

  • 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.

    PubMed 30463611

Questions about this trial

What is this clinical trial studying?

A study testing Surgery for standard axillary node dissection and No axillary lymph node dissection in people with Invasive Breast Cancer, run by Institut Paoli-Calmettes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free survival (time frame: Time to relapse or progression up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01717131, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.

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