Breast Carcinoma T1-T2-T3 / cN +: Axillary Conservation of Lymph Nodes in the Presence of Micro Metastases in Sentinel Lymph Node, in cN- After Neoadjuvant Chemotherapy - Studio NEONOD 2

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: Non applicabile

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Age: 18 ≤75 years
- Breast carcinoma with infiltrating histotype
- Tumor size: cT1 - cT2 - cT3
- Positive axillary lymph nodes (cN +) at the initial diagnosis by clinical, ultrasound and cyto-microhistology evaluation
- Neoadjuvant chemotherapy performed
- Negative axillary lymph nodes (cN-) from the NAC by clinical and ultrasound assessment
- Absence of distant metastases (M0)
- Negative medical history for previous infiltrating breast cancer

Criteri di esclusione: 

- Current pregnancy or lactation status
- Inflammatory breast cancer
- In situ breast cancer
- Synchronous contralateral breast cancer
- Co-morbidity and/or medical disorder precluding any adjuvant therapy
- Co-morbidity and/or medical/mental disorder making impossible making a regular follow-up
- Other cancers in the previous 3 years (except forcarcinoma in situ of the uterine cervix, basalioma, squamous cell carcinoma or non-melanoma skin cancer)

Trattamento sperimentale: 

Group 1: experimental
patients with micro metastatic sentinel lymph node and/or parasentinella lymph node (ypN1mi). Axillary dissection is not performed.
Procedure: Omission of Axillary dissection
In Group 1 and 2: Axillary dissection won't be performed

Group 3: internal control
Patients with macro metastatic sentinel and/or parasentinella lymph nodes (ypN>=1). In these patients standard axillary dissection is performed as standard treatment.
Procedure: Axillary dissection
In Group 3: Axillary dissection will be performed

Trattamento di controllo: 

Group 2: standard
patients with negative sentinel lymph node (ypN0) or with ITC finding (ypN0 / YpN0 (i +)). Axillary dissection is not performed as standard treatment.
Procedure: Omission of Axillary dissection
In Group 1 and 2: Axillary dissection won't be performed 

Obiettivi primari dello studio: 

Disease-free or death-free survival for any reason (DFS) [ Time Frame: 5 years of follow up after surgery ]
    Evaluating whether in patients operated for breast cancer (cT1-T2-T3) with sentinel node micrometastases (SLNypN1mi) after   neoadjuvant chemotherapy (NAC), the preservation of axillary lymph nodes is not associated with a clinically relevant prognostic deterioration using Kaplan-Meier Product Limit Estimator and the log-rank test

Centri partecipanti

Nord Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT04019678

Data di inserimento: 30.03.2020

Promotore

Humanitas Cancer Center

CRO

/

Principal Investigator ITALIA

Riferimento: Dr. Corrado Tinterri

Telefono: 0282244012

Email: corrado.tinterri@cancercenter.humanitas.it

Localita: Rozzano (Mi)