Breast Cancer
Conditions
Keywords
Breast cancer, neoadjuvant chemotherapy, False negative rate, Axillary lymph node dissection, Sentinel lymph node
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.
Interventions
PROCEDUREAxillar Sentinel lymph node biopsy
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.
PROCEDURESLNB and complete level I-II axillary lymphadenectomy
group 1 : patients with proven involved axillary nodes will undergo SLNB and complete level I-II axillary lymphadenectomy.
Sponsors
Institut Cancerologie de l'Ouest
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| false-negative (FN) rate for the Sentinel Lymph Node Detection | 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
| Measure | Time frame | Description |
|---|---|---|
| Detection rate | after surgery | Percentage of patients with SLN detected and isolated intraoperatively |
| Sataloff score on breast tumour | 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 |
| Sataloff score on lymph nodes | 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. |
| Homolateral axillary recurrence rate | 5 years post surgery | Recurrence observed groupe 2 patients (cN0) whitout ALND |
Countries
France
Outcome results
None listed