Clinical trial NCT01221688: Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer
Official title: Evaluation of Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
neoadjuvant chemotherapy
False negative rate
Axillary lymph node dissection
Sentinel lymph node
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2010-10-15
Enrollment: 958
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: false-negative (FN) rate for the Sentinel Lymph Node Detection
timeFrame: after surgery
Secondary outcomes:
measure: Detection rate
timeFrame: after surgery
measure: Sataloff score on breast tumour
timeFrame: after surgery
measure: Sataloff score on lymph nodes
timeFrame: after surgery
measure: Homolateral axillary recurrence rate
timeFrame: 5 years post surgery
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU
city: Angers
country: France
facility: Institut de Cancerologie de L'Ouest
city: Bordeaux
country: France
facility: Institut Bergonié
city: Brest
country: France
facility: CHU
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: La Roche-sur-Yon
country: France
facility: CH
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Berard
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Montpellier
country: France
facility: INSTITUT DE CANCEROLOGIE DE MONTPELLIER Val d'aurelle
city: Nancy
country: France
facility: Institut de Cancérlogie de Lorraine
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: HEGP
city: Saint Herblain
country: France
facility: Institut de cancérologie de l'Ouest
city: Saint-Cloud
country: France
facility: Institut Curie
city: Strasbourg
country: France
facility: ICANS
Study officials:
affiliation: INSTITUT DE CANCEROLOGIE DE L'OUEST
name: Jean-Marc CLASSE, MD
role: PRINCIPAL_INVESTIGATOR
References: