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

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Removal of axillary lymph nodes.
Preservation of axillary lymph nodes
Sponsored by
Fondazione Humanitas per la Ricerca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring axillary dissection, axillary lymph preservation

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Axillary dissection (standard treatment)

    Preservation of axillary lymph nodes

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Regional Disease Free Survival (RDFS)
    Evaluating whether axillary lymph node preservation is associated with a clinically relevant increase of local recurrence rate (ipsilateral axillary and supraclavicular lymph nodes).
    Disease-free distance survival (DDFS)
    Evaluating whether axillary lymph node preservation is associated with a clinically relevant increase in distant recurrence rate.

    Full Information

    First Posted
    November 19, 2021
    Last Updated
    December 16, 2021
    Sponsor
    Fondazione Humanitas per la Ricerca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05160324
    Brief Title
    T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes (SINODAR ONE)
    Acronym
    SINODAR ONE
    Official Title
    T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes in the Presence of Sentinel Lymph Node Metastases (SINODAR ONE)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    April 14, 2015 (Actual)
    Primary Completion Date
    April 30, 2025 (Anticipated)
    Study Completion Date
    April 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondazione Humanitas per la Ricerca

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    axillary dissection, axillary lymph preservation

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    889 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Axillary dissection (standard treatment)
    Arm Type
    Active Comparator
    Arm Description
    Axillary dissection in women with sentinel lymph node metastases. (removal of at least 10 lymph nodes recommended)
    Arm Title
    Preservation of axillary lymph nodes
    Arm Type
    Experimental
    Arm Description
    Omission of Axillary dissection in women with sentinel lymph node metastases.
    Intervention Type
    Procedure
    Intervention Name(s)
    Removal of axillary lymph nodes.
    Intervention Description
    Axillary dissection in patients with positive sentinel lymph node
    Intervention Type
    Procedure
    Intervention Name(s)
    Preservation of axillary lymph nodes
    Intervention Description
    Preservation of axillary lymph nodes in patients with positive sentinel lymph node
    Primary Outcome Measure Information:
    Title
    Overall Survival (OS)
    Description
    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
    Time Frame
    5 years of follow up after surgery
    Secondary Outcome Measure Information:
    Title
    Regional Disease Free Survival (RDFS)
    Description
    Evaluating whether axillary lymph node preservation is associated with a clinically relevant increase of local recurrence rate (ipsilateral axillary and supraclavicular lymph nodes).
    Time Frame
    5 years of follow up after surgery
    Title
    Disease-free distance survival (DDFS)
    Description
    Evaluating whether axillary lymph node preservation is associated with a clinically relevant increase in distant recurrence rate.
    Time Frame
    5 years of follow up after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Corrado Tinterri, MD
    Organizational Affiliation
    Istituto Clinico Humanitas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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