NCT05160324

Brief Summary

Italian Multicentric non inferiority two-arm randomized clinical trial to verify that the experimental treatment (omission of axillary lymph node intervention) in the presence of sentinel lymph node metastases does not lead to a significant worsening in survival or in the risk of locoregional recurrence compared to standard treatment (removal of I-II level of axillary lymph nodes).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
889

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable breast-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2015

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

January 5, 2022

Status Verified

December 1, 2021

Enrollment Period

10.1 years

First QC Date

November 19, 2021

Last Update Submit

December 16, 2021

Conditions

Breast Cancer

Keywords

axillary dissection, axillary lymph preservation

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    Evaluating whether, in women operated for breast cancer (T1-T2) with sentinel lymph node metastases, axillary lymph node conservation is associated with a clinically relevant prognostic worsening (OS). For all the Outcomes Statistical analysis included Kaplan-Meier Product Limit Estimator and the log-rank test

    5 years of follow up after surgery

Secondary Outcomes (2)

  • Regional Disease Free Survival (RDFS)

    5 years of follow up after surgery

  • Disease-free distance survival (DDFS)

    5 years of follow up after surgery

Study Arms (2)

Axillary dissection (standard treatment)

ACTIVE COMPARATOR

Axillary dissection in women with sentinel lymph node metastases. (removal of at least 10 lymph nodes recommended)

Procedure: Removal of axillary lymph nodes.

Preservation of axillary lymph nodes

EXPERIMENTAL

Omission of Axillary dissection in women with sentinel lymph node metastases.

Procedure: Preservation of axillary lymph nodes

Interventions

Removal of axillary lymph nodes.PROCEDURE

Axillary dissection in patients with positive sentinel lymph node

Axillary dissection (standard treatment)
Preservation of axillary lymph nodesPROCEDURE

Preservation of axillary lymph nodes in patients with positive sentinel lymph node

Preservation of axillary lymph nodes

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 40 ≤75 years old
  • Breast cancer with infiltrating histology
  • Tumor size ≤50 mm (T1 - T2)
  • Clinically and ultrasound node-negative (cN0) breast cancer
  • No distant metastases (M0)
  • No neoadjuvant therapy
  • Negative history of previous infiltrating neoplasm
  • Maximum number of metastatic sentinel lymph nodes: 2
  • Lymph node macro-metastases \> 2mm

You may not qualify if:

  • Pregnancy or breastfeeding in progress
  • Inflammatory breast cancer
  • Breast cancer in situ
  • Synchronous contralateral breast cancer
  • Co-morbidities such as to preclude the possible use of adjuvant therapy
  • Conditions that make it impossible to carry out a regular follow-up
  • Other malignancies within the previous 3 years (except carcinoma in situ of the uterine cervix, basalioma or squamous cell ca or non-melanoma skin ca)
  • Breast cancer with non-infiltrating or inflammatory histotype
  • Tumor size\> 50 mm
  • No sentinel lymph nodes identified
  • No positive sentinel lymph nodes (pN0)
  • Positive sentinel lymph node number \> 2
  • Lymph node micro-metastases \<= 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tinterri C, Canavese G, Gatzemeier W, Barbieri E, Bottini A, Sagona A, Caraceni G, Testori A, Di Maria Grimaldi S, Dani C, Boni L, Bruzzi P, Fernandes B, Scorsetti M, Zambelli A, Gentile D; SINODAR-ONE Collaborative Group. Sentinel lymph node biopsy versus axillary lymph node dissection in breast cancer patients undergoing mastectomy with one to two metastatic sentinel lymph nodes: sub-analysis of the SINODAR-ONE multicentre randomized clinical trial and reopening of enrolment. Br J Surg. 2023 Aug 11;110(9):1143-1152. doi: 10.1093/bjs/znad215.

    PMID: 37471574DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Corrado Tinterri, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2021

First Posted

December 16, 2021

Study Start

April 14, 2015

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

January 5, 2022

Record last verified: 2021-12