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NCT Number: NCT01221688

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Axillar Sentinel lymph node biopsy

Procedure

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 lymphadenectomy

Procedure

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

Primary outcomes

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

    Time frame: after surgery

    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

Secondary outcomes

  1. Detection rate

    Time frame: after surgery

    Percentage of patients with SLN detected and isolated intraoperatively

  2. Sataloff score on breast tumour

    Time frame: after surgery

    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

  3. Sataloff score on lymph nodes

    Time frame: after surgery

    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.

  4. Homolateral axillary recurrence rate

    Time frame: 5 years post surgery

    Recurrence observed groupe 2 patients (cN0) whitout ALND

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

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

Acronym: GANEA2

Important dates

Study start
2010
Primary completion
2014
Study completion
2019
First posted
Oct 15, 2010
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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