T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes (SINODAR ONE) (SINODAR ONE)

December 16, 2021 updated by: Fondazione Humanitas per la Ricerca

T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes in the Presence of Sentinel Lymph Node Metastases (SINODAR ONE)

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Detailed Description:

The trial is a non-inferiority trial; patients, depending on intra-operative or post-operative sentinel lymph node assessment, are randomly assigned to one of the two intervention groups:

group 1: removal of I-II level of axillary lymph nodes (standard treatment). Removal of at least 10 lymph nodes is recommended.

group 2: no axillary lymph nodes dissection (experimental treatment). Patients for whom sentinel lymph node cannot be found, will undergo complete dissection of the axillary cavity as required by international guidelines.

After surgery, according to their bio-pathological profile and to the international guidelines criteria, patients will be able to receive:

  • no further treatment
  • complementary radiotherapy
  • adjuvant medical therapy (chemo and / or hormone therapy).

Patients will be checked for at least 5 years in the following ways:

  • six-monthly clinical examination for the first 5 years and yearly thereafter
  • mammography + annual breast ultrasound
  • annual axillary ultrasound in cases not subjected to dissection.

Study Type

Interventional

Enrollment (Actual)

889

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Axillary dissection (standard treatment)

Axillary dissection in women with sentinel lymph node metastases.

(removal of at least 10 lymph nodes recommended)
Procedure: Removal of axillary lymph nodes.
Axillary dissection in patients with positive sentinel lymph node
Experimental: Preservation of axillary lymph nodes
Omission of Axillary dissection in women with sentinel lymph node metastases.
Procedure: Preservation of axillary lymph nodes
Preservation of axillary lymph nodes in patients with positive sentinel lymph node

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 5 years of follow up after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional Disease Free Survival (RDFS)
Time Frame: 5 years of follow up after surgery
Evaluating whether axillary lymph node preservation is associated with a clinically relevant increase of local recurrence rate (ipsilateral axillary and supraclavicular lymph nodes).
5 years of follow up after surgery
Disease-free distance survival (DDFS)
Time Frame: 5 years of follow up after surgery
Evaluating whether axillary lymph node preservation is associated with a clinically relevant increase in distant recurrence rate.
5 years of follow up after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Humanitas per la Ricerca

Investigators

  • Principal Investigator: Corrado Tinterri, MD, Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2015

Primary Completion (Anticipated)

April 30, 2025

Study Completion (Anticipated)

April 30, 2025

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2022

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1317

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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