NCT04019678

Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes.

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 850 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Italian multicentric non inferiority clinical study to verify whether the omission of axillary lymph node intervention in patients with SLN (Sentinel Lymph Nodes) ypN1mi after NAC (Neo Adiuvant Chemotherapy) does not lead to a significant deterioration in survival or in the risk of regional or distant recurrence, compared to patients with negative SLN (SLN ypN0) after NAC ,where the omission of axillary treatment is currently the standard treatment.

Detailed description

The study includes patients with cN+ positive axillary lymph nodes at initial diagnosis and who also have negative clinical and instrumental evaluation after NAC. Based on the sentinel lymph nodes definitive histological evaluation patients are allocated in one of the 2 comparison groups (Group 1 experimental or Group 2 standard) or in Group 3 internal control group. Group 3 is not used in statistical comparison with the other two groups but it's aim is to evaluate the appropriateness of the cases. Referring to bio-pathologic characteristics after surgery patients will receive: * no further treatment * complementary radiotherapy * adjuvant medical therapy (hormonal therapy and/or biological therapy) Irradiation: Group 1 (experimental) and Group 2 (standard): irradiation won't be performed neither in the axillary region nor in the other lymph node stations Group 3 (internal control): after conservative or radical surgery, patients will be subjected to loco-regional irradiation according to Guidelines. Duration: Patients enrollment in the study protocol will last for 3 years. Patients will have to be followed for the subsequent 5 years during which they will have to undergo to periodic visits and follow-up checks provided for by the current standard guidelines: * clinical examination every six months for the first 5 years * mammography and breast ultrasound yearly * axillary ultrasound yearly

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Omission of Axillary dissection	In Group 1 and 2: Axillary dissection won't be performed

Timeline

• Start date: 2019-06-21
• Primary completion: 2027-06-21
• Completion: 2027-06-21
• First posted: 2019-07-15
• Last updated: 2021-04-19

Locations

1 site across 1 country: Italy