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
About this trial
This is an interventional other trial for Breast Cancer focused on measuring axillary dissection, axillary lymph preservation
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
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
NCT ID
NCT05160324
First Posted
November 19, 2021
Last Updated
December 16, 2021
Sponsor
Fondazione Humanitas per la Ricerca
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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