Breast CancerNEONOD2NCT04019678
Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes.
A study testing Omission of Axillary dissection in people with Breast Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Italian multicentric non inferiority clinical study to verify whether the omission of axillary lymph node intervention in patients with SLN (Sentinel Lymph Nodes) ypN1mi after NAC (Neo Adiuvant Chemotherapy) does not lead to a significant deterioration in survival or in the risk of regional or distant recurrence… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Omission of Axillary dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jun 2019to 21 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 ≤75 years
- Breast carcinoma with infiltrating histotype
- Tumor size: cT1 - cT2 - cT3
- Positive axillary lymph nodes (cN +) at the initial diagnosis by clinical, ultrasound and cyto-microhistology evaluation
- Neoadjuvant chemotherapy performed
- Negative axillary lymph nodes (cN-) from the NAC by clinical and ultrasound assessment
- Absence of distant metastases (M0)
- Negative medical history for previous infiltrating breast cancer
Who cannot join
- Current pregnancy or lactation status
- Inflammatory breast cancer
- In situ breast cancer
- Synchronous contralateral breast cancer
- Co-morbidity and/or medical disorder precluding any adjuvant therapy
- Co-morbidity and/or medical/mental disorder making impossible making a regular follow-up
- Other cancers in the previous 3 years (except forcarcinoma in situ of the uterine cervix, basalioma, squamous cell carcinoma or non-melanoma skin cancer)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico Humanitas
Rozzano, MI, 20089
Corrado Tinterri, MD, +390282244012, corrado.tinterri@cancercenter.humanitas.it
About this study
Official title: Breast Carcinoma T1-T2-T3 / cN +: Axillary Conservation of Lymph Nodes in the Presence of Micro Metastases in Sentinel Lymph Node, in cN- After Neoadjuvant Chemotherapy - Studio NEONOD 2
Italian multicentric non inferiority clinical study to verify whether the omission of axillary lymph node intervention in patients with SLN (Sentinel Lymph Nodes) ypN1mi after NAC (Neo Adiuvant Chemotherapy) does not lead to a significant deterioration in survival or in the risk of regional or distant recurrence, compared to patients with negative SLN (SLN ypN0) after NAC ,where the omission of axillary treatment is currently the standard treatment.
Read the detailed description
The study includes patients with cN+ positive axillary lymph nodes at initial diagnosis and who also have negative clinical and instrumental evaluation after NAC. Based on the sentinel lymph nodes definitive histological evaluation patients are allocated in one of the 2 comparison groups (Group 1 experimental or Group 2 standard) or in Group 3 internal control group. Group 3 is not used in statistical comparison with the other two groups but it's aim is to evaluate the appropriateness of the cases.
Referring to bio-pathologic characteristics after surgery patients will receive:
- no further treatment
- complementary radiotherapy
- adjuvant medical therapy (hormonal therapy and/or biological therapy)
Irradiation:
Group 1 (experimental) and Group 2 (standard): irradiation won't be performed neither in the axillary region nor in the other lymph node stations
Group 3 (internal control): after conservative or radical surgery, patients will be subjected to loco-regional irradiation according to Guidelines.
Duration:
Patients enrollment in the study protocol will last for 3 years. Patients will have to be followed for the subsequent 5 years during which they will have to undergo to periodic visits and follow-up checks provided for by the current standard guidelines:
- clinical examination every six months for the first 5 years
- mammography and breast ultrasound yearly
- axillary ultrasound yearly
- Conditions
- Breast Cancer
- Being tested
- Omission of Axillary dissection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omission of Axillary dissectionProcedure or surgery
In Group 1 and 2: Axillary dissection won't be performed
| Study group | Role | What they receive |
|---|---|---|
| Group 1: experimental | Experimental | patients with micro metastatic sentinel lymph node and/or parasentinella lymph node (ypN1mi). Axillary dissection is not performed. Receives: Procedure: Omission of Axillary dissection |
| Group 2: standard | Active comparator | patients with negative sentinel lymph node (ypN0) or with ITC finding (ypN0 / YpN0 (i +)). Axillary dissection is not performed as standard treatment. Receives: Procedure: Omission of Axillary dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free or death-free survival for any reason (DFS)
Evaluating whether in patients operated for breast cancer (cT1-T2-T3) with sentinel node micrometastases (SLNypN1mi) after neoadjuvant chemotherapy (NAC), the preservation of axillary lymph nodes is not associated with a clinically relevant prognostic deterioration using Kaplan-Meier Product Limit Estimator and the log-rank test
Measured: 5 years of follow up after surgery
Secondary outcomes (3)
Global Survival (OS)
Kaplan-Meier Product Limit Estimator and the log-rank test
Measured: 5 years of follow up after surgery
Regional Disease Free Survival (RDFS)
Kaplan-Meier Product Limit Estimator and the log-rank test
Measured: 5 years of follow up after surgery
Disease-free distance survival (DDFS)
Kaplan-Meier Product Limit Estimator and the log-rank test
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 posted15 Jul 2019
- Study start21 Jun 2019
- Primary completion21 Jun 2027 (estimated)
- Study completion21 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- 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
- NCT04019678
- Sponsor's protocol ID
- 651
- Acronym
- NEONOD2
- Status last verified
- Nov 2020
- First submitted
- 10 Jul 2019
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Carcinoma T1-T2-T3 / cN +: Axillary Conservation of Lymph Nodes in the Presence of Micro Metastases in Sentinel Lymph Node, in cN- After Neoadjuvant Chemotherapy - Studio NEONOD 2
- ClinicalTrials.gov ID
- NCT04019678
- Acronym / sponsor ID
- NEONOD2 / 651
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 21 Jun 2027 (estimated)
- Study completion
- 21 Jun 2027 (estimated)
- First posted
- 15 Jul 2019 (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 clinical study to verify whether the omission of axillary lymph node intervention in patients with SLN (Sentinel Lymph Nodes) ypN1mi after NAC (Neo Adiuvant Chemotherapy) does not lead to a significant deterioration in survival or in the risk of regional or distant recurrence, compared to patients with negative SLN (SLN ypN0) after NAC ,where the omission of axillary treatment is currently the standard treatment.
Detailed description
The study includes patients with cN+ positive axillary lymph nodes at initial diagnosis and who also have negative clinical and instrumental evaluation after NAC. Based on the sentinel lymph nodes definitive histological evaluation patients are allocated in one of the 2 comparison groups (Group 1 experimental or Group 2 standard) or in Group 3 internal control group. Group 3 is not used in statistical comparison with the other two groups but it's aim is to evaluate the appropriateness of the cases.
Referring to bio-pathologic characteristics after surgery patients will receive:
- no further treatment
- complementary radiotherapy
- adjuvant medical therapy (hormonal therapy and/or biological therapy)
Irradiation:
Group 1 (experimental) and Group 2 (standard): irradiation won't be performed neither in the axillary region nor in the other lymph node stations
Group 3 (internal control): after conservative or radical surgery, patients will be subjected to loco-regional irradiation according to Guidelines.
Duration:
Patients enrollment in the study protocol will last for 3 years. Patients will have to be followed for the subsequent 5 years during which they will have to undergo to periodic visits and follow-up checks provided for by the current standard guidelines:
- clinical examination every six months for the first 5 years
- mammography and breast ultrasound yearly
- axillary ultrasound yearly
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: experimental | Experimental | Procedure: Omission of Axillary dissectionpatients with micro metastatic sentinel lymph node and/or parasentinella lymph node (ypN1mi). Axillary dissection is not performed. |
| Group 2: standard | Active comparator | Procedure: Omission of Axillary dissectionpatients with negative sentinel lymph node (ypN0) or with ITC finding (ypN0 / YpN0 (i +)). Axillary dissection is not performed as standard treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18 ≤75 years
- Breast carcinoma with infiltrating histotype
- Tumor size: cT1 - cT2 - cT3
- Positive axillary lymph nodes (cN +) at the initial diagnosis by clinical, ultrasound and cyto-microhistology evaluation
- Neoadjuvant chemotherapy performed
Key exclusion criteria (7 listed)
- Current pregnancy or lactation status
- Inflammatory breast cancer
- In situ breast cancer
- Synchronous contralateral breast cancer
- Co-morbidity and/or medical disorder precluding any 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 |
|---|---|---|
| Omission of Axillary dissectionIn Group 1 and 2: Axillary dissection won't be performed | Procedure or surgery | Group 1: experimental, Group 2: standard |
Primary outcome
Disease-free or death-free survival for any reason (DFS)
Time frame: 5 years of follow up after surgery
Evaluating whether in patients operated for breast cancer (cT1-T2-T3) with sentinel node micrometastases (SLNypN1mi) after neoadjuvant chemotherapy (NAC), the preservation of axillary lymph nodes is not associated with a clinically relevant prognostic deterioration using Kaplan-Meier Product Limit Estimator and the log-rank test
3 secondary outcomes
Global Survival (OS)
Time frame: 5 years of follow up after surgery
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
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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.
Corrado Tinterri, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omission of Axillary dissection in people with Breast Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corrado Tinterri, MD (+390282244012, corrado.tinterri@cancercenter.humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free or death-free survival for any reason (DFS) (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?
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 19 Apr 2021.