Recruiting

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

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.

ClinicalTrials.gov IDNCT04019678

PhaseNA

Enrollment850

SponsorIstituto Clinico Humanitas

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer

About this study

Interventions

Procedure: Omission of Axillary dissection — In Group 1 and 2: Axillary dissection won't be performed

Primary outcomes

Disease-free or death-free survival for any reason (DFS) (5 years of follow up after surgery)

Eligibility information

Inclusion Criteria: 1. Age: 18 ≤75 years 2. Breast carcinoma with infiltrating histotype 3. Tumor size: cT1 - cT2 - cT3 4. Positive axillary lymph nodes (cN +) at the initial diagnosis by clinical, ultrasound and cyto-microhistology evaluation 5. Neoadjuvant chemotherapy performed 6. Negative axillary lymph nodes (cN-) from the NAC by clinical and ultrasound assessment 7. Absence of distant metastases (M0) 8. Negative medical history for previous infiltrating breast cancer Exclusion Criteria: 1. Current pregnancy or lactation status 2. Inflammatory breast cancer 3. In situ breast cancer 4. Synchronous contralateral breast cancer 5. Co-morbidity and/or medical disorder precluding any adjuvant therapy 6. Co-morbidity and/or medical/mental disorder making impossible making a regular follow-up 7. Other cancers in the previous 3 years (except forcarcinoma in situ of the uterine cervix, basalioma, squamous cell carcinoma or non-melanoma skin cancer)

Study locations

Istituto Clinico Humanitas, Rozzano, MI 20089 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.