Breast CancerSINODAR ONENCT05160324
T1-T2 Breast Cancer: Comparison Between Removal and Preservation of Axillary Lymph Nodes (SINODAR ONE)
A study testing Removal of axillary lymph nodes. and Preservation of axillary lymph nodes in people with Breast Cancer, run by Fondazione Humanitas per la Ricerca.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Removal of axillary lymph nodes. and Preservation of axillary lymph nodes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 889 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2015to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Negative history of previous infiltrating neoplasm
- Maximum number of metastatic sentinel lymph nodes: 2
- Lymph node macro-metastases > 2mm
Who cannot join
- 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
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- 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
About this study
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)
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).
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Removal of axillary lymph nodes., Preservation of axillary lymph nodes
- Keywords
- axillary dissection, axillary lymph preservation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of axillary lymph nodes.Procedure or surgery
Axillary dissection in patients with positive sentinel lymph node
Preservation of axillary lymph nodesProcedure or surgery
Preservation of axillary lymph nodes in patients with positive sentinel lymph node
| Study group | Role | What they receive |
|---|---|---|
| Axillary dissection (standard treatment) | Active comparator | Axillary dissection in women with sentinel lymph node metastases.
(removal of at least 10 lymph nodes recommended) Receives: Procedure: Removal of axillary lymph nodes. |
| Preservation of axillary lymph nodes | Experimental | Omission of Axillary dissection in women with sentinel lymph node metastases. Receives: Procedure: Preservation of axillary lymph nodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years of follow up after surgery
Secondary outcomes (2)
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).
Measured: 5 years of follow up after surgery
Disease-free distance survival (DDFS)
Evaluating whether axillary lymph node preservation is associated with a clinically relevant increase in distant recurrence rate.
Measured: 5 years of follow up after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start14 Apr 2015
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 889 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Humanitas per la Ricerca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corrado Tinterri, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160324
- Sponsor's protocol ID
- 1317
- Acronym
- SINODAR ONE
- Status last verified
- Dec 2021
- First submitted
- 19 Nov 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37471574
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05160324
- Acronym / sponsor ID
- SINODAR ONE / 1317
- Conditions
- Breast Cancer
- Keywords
- axillary dissection, axillary lymph preservation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 889 participants (actual)
- Lead sponsor
- Fondazione Humanitas per la RicercaUniversity, hospital or other
- Study start
- 14 Apr 2015 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axillary dissection (standard treatment) | Active comparator | Procedure: Removal of axillary lymph nodes.Axillary dissection in women with sentinel lymph node metastases. (removal of at least 10 lymph nodes recommended) |
| Preservation of axillary lymph nodes | Experimental | Procedure: Preservation of axillary lymph nodesOmission of Axillary dissection in women with sentinel lymph node metastases. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removal of axillary lymph nodes.Axillary dissection in patients with positive sentinel lymph node | Procedure or surgery | Axillary dissection (standard treatment) |
| Preservation of axillary lymph nodesPreservation of axillary lymph nodes in patients with positive sentinel lymph node | Procedure or surgery | Preservation of axillary lymph nodes |
Primary outcome
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
2 secondary outcomes
Regional Disease Free Survival (RDFS)
Time frame: 5 years of follow up after surgery
Disease-free distance survival (DDFS)
Time frame: 5 years of follow up after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Derived from this study: PubMed 37471574Tinterri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corrado Tinterri, MD principal investigator
Istituto Clinico Humanitas
Questions about this trial
What is this clinical trial studying?
A study testing Removal of axillary lymph nodes. and Preservation of axillary lymph nodes in people with Breast Cancer, run by Fondazione Humanitas per la Ricerca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 5 years of follow up after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05160324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.