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Breast CancerGANEA2NCT01221688

Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer

A study testing Axillar Sentinel lymph node biopsy and SLNB and complete level I-II axillary lymphadenectomy in people with Breast Cancer, run by Institut Cancerologie de l'Ouest at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Neoadjuvant chemotherapy (NAC) is frequently proposed to patients with large tumours that can be operated in order to increase the chances of breast conservation. After NAC, patients are operated with systematic axillary lymph node dissection (ALND), although more than half of these patients do not have lymph node… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Axillar Sentinel lymph node biopsy and SLNB and complete level I-II axillary lymphadenectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
958 participants
Where
18 sitesFrance
Study dates
12 Jul 2010to 10 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

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

  • T2-T3 operable infiltrating breast carcinoma
  • No allergy to Patent Blue
  • Pre-operative diagnosis of unifocal infiltrating breast carcinoma.
  • Patient planned to be treated by NAC.
  • Informed consent.
  • Surgery available 4 to 6 weeks after the last chemotherapy course (radical or conservative surgery)

Who cannot join

  • pT4d (inflammatory breast cancer)
  • Locally advanced or metastatic breast cancer
  • Any previous chemotherapy of contra-lateral breast cancer.
  • Breast cancer local relapse
  • Previous surgical removal of breast Cancer.
  • Inadequate biopsy for pathological analysis.
Show all 10Show fewer
  • Dementia or altered mental disorder
  • Pregnant woman or breast feeding or without efficacious contraceptive method.
  • Contra-indication to NAC NAC interrupted due to progressive disease.
  • Neoadjuvant radiotherapy.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • CHU

    Angers, 49 933

  • Institut de Cancerologie de L'Ouest

    Angers, 49055

  • Institut Bergonié

    Bordeaux, 33000

  • CHU

    Brest, 29609

  • Centre Jean Perrin

    Clermont-Ferrand

  • CH

    La Roche-sur-Yon, 85925

  • Centre Oscar Lambret

    Lille, 59000

  • Centre Léon Berard

    Lyon, 69 000

  • Institut Paoli Calmette

    Marseille, 13009

  • INSTITUT DE CANCEROLOGIE DE MONTPELLIER Val d'aurelle

    Montpellier, 34298

  • Institut de Cancérlogie de Lorraine

    Nancy, 54511

  • Institut Curie

    Paris, 75 000

  • Hôpital Européen Georges Pompidou

    Paris, 75000

  • Hôpital Lariboisière

    Paris, 75000

  • HEGP

    Paris, 75908

  • Institut Curie

    Saint-Cloud, 92210

  • Institut de cancérologie de l'Ouest

    Saint-Herblain, 44805

  • ICANS

    Strasbourg

Other trials in France

About this study

Official title: Evaluation of Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer

Neoadjuvant chemotherapy (NAC) is frequently proposed to patients with large tumours that can be operated in order to increase the chances of breast conservation. After NAC, patients are operated with systematic axillary lymph node dissection (ALND), although more than half of these patients do not have lymph node involvement. These results lead us to consider the indication of the sentinel lymph node (SLN) technique after NAC in order to avoid unnecessary ALND in patients whose SLN is free of involvement.

We need to validate the SLN technique after NAC in patients who have proven lymph node involvement prior to NAC.

GANEA2 is a new trial based on patient treated for a large breast tumor with proven axillary involved nodes. Patients enrolled in this trial will have first an axillary sonography with fine needle punction in case of suspected nodes before NAC. This primary evaluation allow to determine two groups of patients : group 1 (pN+) : patients with proven involved axillary nodes and group 2, patients without proven axillary involved nodes (cN0). Patients of group 1, will undergo SLNB and complete level I-II axillary lymphadenectomy. Patients of group 2 will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.

Conditions
Breast Cancer
Being tested
Axillar Sentinel lymph node biopsy, SLNB and complete level I-II axillary lymphadenectomy
Keywords
Breast cancer, neoadjuvant chemotherapy, False negative rate, Axillary lymph node dissection, Sentinel lymph node
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Axillar Sentinel lymph node biopsyProcedure or surgery

    Group 2 : Patients without proven axillary involved nodes will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.

  • SLNB and complete level I-II axillary lymphadenectomyProcedure or surgery

    group 1 : patients with proven involved axillary nodes will undergo SLNB and complete level I-II axillary lymphadenectomy.

Study groups in NCT01221688
Study groupRoleWhat they receive
group 2 (cN0)OtherPatients without proven axillary involved nodes will undergo SLN biopsy and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLN biopsy alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.
Receives: Procedure: Axillar Sentinel lymph node biopsy
group 1 (pN+)Experimentalgroup 1 : patients with proven involved axillary nodes will undergo SLN biopsy and complete level I-II axillary lymphadenectomy.
Receives: Procedure: SLNB and complete level I-II axillary lymphadenectomy

What is being measured

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

  1. false-negative (FN) rate for the Sentinel Lymph Node Detection

    Ratio of the number of FN cases to the total number of patients with at least one lymph node involved, sentinel or not.

    a FN case was defined as a patient with a successful mapping, SLN(s) without any metastasis, and a metastasis in at least one node from the ALND

    Measured: after surgery

Secondary outcomes (4)

  1. Detection rate

    Percentage of patients with SLN detected and isolated intraoperatively

    Measured: after surgery

  2. Sataloff score on breast tumour

    The Sataloff classification assesses the response of the NAC on the breast tissue.

    TA: total or almost total therapeutic effect. TB: therapeutic effect > 50%. TC: < 50% therapeutic effect but obvious effect. TD: no therapeutic effect

    Measured: after surgery

  3. Sataloff score on lymph nodes

    The Sataloff classification assesses the response of the NAC on the lymph nodes NA: clear therapeutic effect, no metastases. NB: no therapeutic effect, no metastases. NC: aspects of therapeutic effect, but presence of metastases. ND: no therapeutic effect, viable metastases.

    Measured: after surgery

  4. Homolateral axillary recurrence rate

    Recurrence observed groupe 2 patients (cN0) whitout ALND

    Measured: 5 years post surgery

Timeline

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

  1. First posted15 Oct 2010 (estimated)
  2. Study start12 Jul 2010
  3. Primary completion27 Oct 2014
  4. Study completion10 Dec 2019

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Early breast cancer patients treated with neo-adjuvant chemotherapy (NAC) were included. Before NAC, patients with cytologically proven node involvement were allocated into the pN1 group, other patient were allocated into the cN0 group. After NAC, pN1 group patients underwent sentinel lymph node (SLN) and axillary lymph node dissection (ALND); cN0 group patients underwent SLN and ALND only in case of mapping failure or SLN involvement.
Masking
None (open label)
Enrolment
958 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01221688
Sponsor's protocol ID
BRD 09/9-G
Acronym
GANEA2
Status last verified
Apr 2022
First submitted
11 Oct 2010
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Axillar Sentinel lymph node biopsy and SLNB and complete level I-II axillary lymphadenectomy in people with Breast Cancer, run by Institut Cancerologie de l'Ouest at 18 sites 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

false-negative (FN) rate for the Sentinel Lymph Node Detection (time frame: after surgery). 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 NCT01221688.

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 25 Apr 2022.

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