Breast CancerNodeSMARTNCT07085442
Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
An observational study of Breast Cancer and Axillary Lymph Nodes Dissection, run by University Hospitals of Derby and Burton NHS Foundation Trust at 14 sites in United Kingdom.
Trial summary
Axillary ultrasound scan (AUS) is routinely employed in the UK for preoperative axillary staging and can diagnose approximately 50 - 80% of node positive patients when combined with percutaneous needle biopsy techniques (either core-biopsy or fine-needle aspiration cytology). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Axillary Lymph Nodes Dissection, Axillary Metastases
- What is being tested?
- Targeted Sentinel Node Biopsy (TSNB)
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- 17 Jan 2025to Dec 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cT1-2N1M0 breast cancer patients aged 18 years or older, with needle biopsy proven nodal metastases, ≤2 abnormal nodes on imaging, and are undergoing sentinel node biopsy and removal of the marked involved node.
Who may be able to join
- cT1-2N1M0 breast cancer*
- FNA or core biopsy confirmed axillary nodal metastases
- ≤2 abnormal nodes on imaging
- The biopsied involved node should be marked using any technique
- Undergo a dual tracer or single tracer sentinel node biopsy with removal of the marked node (Targeted Sentinel Node Biopsy, TSNB)‡
- If the sentinel node(s) cannot be localised, axillary node sampling may be performed *patients with T3 tumours on post-operative histology will remain eligible. For multifocal/multicentric tumours, the cT stage is based on the size of the largest invasive tumour focus rather than the combined size of all tumours.
- cN1 includes nodes detected by imaging studies or clinical examination.
- ‡If the marked node cannot be localised, patient will remain in NodeSMART. The decision regarding any further axillary treatment will be made by the treating MDT and recorded in the audit.
Who cannot join
- Neoadjuvant chemotherapy†
- Previous ipsilateral axillary lymph node dissection
- cT3-4 breast cancer
- ≥3 abnormal nodes on imaging
- Neoadjuvant endocrine therapy is permitted.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United Kingdom14 sites, 14 recruiting
- Recruiting
Burnley General Teaching Hospital
Burnley
Inder Kumar, Inder.Kumar@elht.nhs.uk
Inder Kumar
- Recruiting
Addenbrooke's Hospital
Cambridge
Eleftheria Kleidi, eleftheria.kleidi@nhs.net
James Worsfold
- Recruiting
University Hospitals of Derby and Burton
Derby
Emanuele Garreffa, emanuele.garreffa@nhs.net
Ruth Parks
- Recruiting
Gartnavel General Hospital
Glasgow
Laszlo Romics, laszlo.romics2@nhs.scot
Laszlo Romics
- Recruiting
Wycombe Hospital
High Wycombe, HP11 2TT
Fiona Tsang-Wright, fiona.tsangwright@nhs.net
Fiona Tsang-Wright
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester
Monika Kaushik, monika.kaushik1@nhs.net
Monika Kaushik
- Recruiting
Liverpool University Hospitals NHS Foundation Trust
Liverpool
Julia Henderson
Julia Henderson
- Recruiting
Royal Alexandra Hospital
Paisley
Laura Arthur
Mhairi Mactier
- Recruiting
The Shrewsbury and Telford Hospital NHS Trust
Shrewsbury
Kaustuv Das, 01743 261000, kaustuv.das@nhs.net
Kaustuv Das
- Recruiting
Mersey and West Lancashire Teaching Hospitals
St Helens
Leena Chagla, Leena.Chagla@merseywestlancs.nhs.uk
Amy Robinson
- Recruiting
University Hospital of North Tees and Hartlepool
Stockton-on-Tees
Rebecca Wilson, rebeccateasdale@nhs.net
Rebecca Wilson
- Recruiting
Warrington and Halton Teaching Hospitals
Warrington
Hudhaifah Shaker, h.shaker@nhs.net
Hudhaifah Shaker
- Recruiting
University Hospital Wishaw
Wishaw
Elizabeth Morrow, Elizabeth.Morrow@lanarkshire.scot.nhs.uk
Elizabeth Morrow
- Recruiting
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
Senthurun Mylvaganam, 01902 307999, senthurun.mylvaganam@nhs.net
Senthurun Mylvaganam
About this study
Official title: NodeSMART - Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
Axillary ultrasound scan (AUS) is routinely employed in the UK for preoperative axillary staging and can diagnose approximately 50 - 80% of node positive patients when combined with percutaneous needle biopsy techniques (either core-biopsy or fine-needle aspiration cytology). It is recognised that nodal burden is generally higher in clinically node negative patients with abnormal nodes on AUS and confirmed on needle-biopsy to be histologically positive than patients diagnosed as node positive on sentinel node biopsy (SNB). However, up to 40% of biopsy-proven node positive patients are found to have fewer than 3 involved nodes on subsequent axillary lymph node dissection (ALND) and are potential candidates for less extensive axillary surgery with axillary radiotherapy (ART) rather than ALND. The total number of abnormal nodes on ultrasound is a key predictor of overall nodal tumour burden.
The AMAROS and OTOASOR trials randomised patients with up to 2 positive sentinel nodes to either ALND or ART. These trials were conducted around the turn of the millennium and before routine use of AUS and therefore would have included a significant number of patients who were radiologically node positive (cN1). Likewise, the ACOSOG Z0011 trial that randomised a similar group of patients to either ALND or observation only, did not incorporate routine AUS and would have included some (radiological) cN1 patients. These trials revealed no adverse impact on disease-free or overall survival from omission of completion ALND.
Read more
Targeted axillary dissection (TAD) was introduced a few years ago to reduce the false negative rate of SNB following neoadjuvant chemotherapy (NACT) and has been standardised as part of the ongoing ATNEC trial [ClinicalTrials.govNCT04109079]. This technique for axillary staging after NACT is increasingly being adopted in the UK and elsewhere. TAD is technically more straightforward and less challenging in patients undergoing primary surgery with no concerns about clip migration consequent to nodal shrinkage as part of treatment response to NACT. Furthermore, the risk of under-treating the axilla is offset by the protocol: if no disease is identified in the targeted nodes (false-negative case), then patients proceed to ALND, thereby ensuring adequate treatment. Unlike TAD following NACT, the presence of viable tumour within the sampled nodes is mandatory and finding fibrosis is irrelevant except as a response to nodal biopsy per se.
Current ASCO guidelines support both SNB and TAD as staging options for patients with ultrasound-detected, biopsy-confirmed nodal disease. The Edinburgh randomised trials comparing four-node sampling with ALND demonstrated significantly lower arm morbidity with node sampling, supporting TAD as a less morbid appropriate alternative in this patient population.
The UK-ANZ POSNOC trial randomised 1,900 patients with <3 macrometastases to either no further axillary treatment or additional axillary treatment. The study included cN1 patients with biopsy-confirmed nodal metastases who underwent sentinel node biopsy or TAD. Patients with <3 macrometastases on final histology were randomised to receive no further axillary treatment or proceed with additional axillary treatment (ALND or ART). POSNOC trial will answer whether further axillary treatment provides any benefit in patients with low volume nodal disease on SNB or TAD.
Notably, patients with biopsy-confirmed metastases and <3 macrometastases on SNB/TAD are biologically and clinically similar to patients with normal AUS who are later found to have low-volume disease on SNB. Clinical decision-making and patient outcomes are driven by tumour biology and overall disease burden rather than the method of nodal disease detection. Furthermore, AUS sensitivity is operator dependent and whether FNA or core biopsy was used to sample the node. A patient considered node negative on AUS by one radiologist may be diagnosed with core biopsy confirmed nodal metastases with another radiologist. Pending the results of POSNOC trial, patients with less than 3 macrometastases are generally advised further axillary treatment, and ART is preferred over ALND to reduce the risk of lymphoedema.
NodeSMART is a prospective audit collecting data on patients undergoing TAD in the primary surgery setting. Its goal is to audit surgical outcomes and benchmark them against - a) Comparing technical outcomes with those from sentinel node biopsy in the primary surgery setting and TAD performed after neoadjuvant chemotherapy. b) Assessing rates of arm lymphoedema and disease progression relative to findings from the AMAROS and Z11 trials, and the POSNOC trial once results are available. The term "Targeted Axillary Dissection" is somewhat misleading in this context, as the marked (biopsied) node is removed alongside sentinel nodes - not in isolation. NodeSMART therefore refers to the procedure more accurately as Targeted Sentinel Node Biopsy (TSNB).
Read the detailed description
Guidelines for node marking:
Node marking is required for NodeSMART. Sites are advised to follow the the best practice node marking standards used in the ongoing ATNEC breast cancer trial. At least three nodes should be removed to allow adequate assessment of nodal tumour burden.
Timing:
The node may be marked at the time of needle biopsy or at a separate visit.
Technique:
Node may be marked using any technique e.g. clip or coil (with or without skin mark), black dye, magnetic seeds or reflector.
If the marked node is not identified or less than three nodes are found on histology, patient will remain in NodeSMART. The decision regarding any further axillary treatment will be made by the treating MDT and recorded in the audit.
Single vs multiple node marking:
It is not necessary to mark more than one node, even if multiple nodes are biopsied or appear malignant. The most abnormal-appearing node should be marked.
Post TSNB axillary treatment:
Further axillary treatment following TSNB will be decided by the treating MDT as per local protocols.
- Conditions
- Breast Cancer, Axillary Lymph Nodes Dissection, Axillary Metastases, Sentinel Lymph Node Biopsy (SLNB), Node Positive Breast Cancer, Axilla; Breast
- Being tested
- Targeted Sentinel Node Biopsy (TSNB)
- Keywords
- Targeted Axillary Dissection, Targeted Sentinel Node Biopsy, NodeSMART, Breast Cancer, Sentinel Node Biopsy, Axillary Lymph Nodes Dissection, Axillary Node Clearance
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Sentinel Node Biopsy (TSNB)Procedure or surgery
Targeted Sentinel Node Biopsy will be performed according to routine local practice. The procedure has been standardised for the post-NACT setting as part of the ongoing ATNEC trial. Sites are advised to follow the ATNEC protocol in the primary surgery setting, using either a dual- or single-tracer sentinel node biopsy technique, with localisation and removal of the marked biopsy proven positive node, and removal of at least 3 nodes.
Axillary treatment following TSNB will be determined according to local MDT recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Patients with biopsy proven nodal metastases (cN1) and not receiving neoadjuvant chemotherapy | Patients with T1 or T2 tumours at presentation with biopsy proven nodal metastases (cN1) and with ≤2 abnormal nodes on axillary ultrasound Receives: Procedure: Targeted Sentinel Node Biopsy (TSNB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with ≤2 nodal metastases identified on histology.
To determine the number of patients with fewer than 3 nodal metastases on final histology, and assess whether ultrasound-detected abnormal nodes and tumour characteristics can predict axillary nodal burden.
Measured: 12 months
Patients with ≤2 nodal metastases identified on histology.
To determine the number of patients with fewer than 3 nodal metastases on final histology, and assess whether ultrasound-detected abnormal nodes and tumour characteristics can predict axillary nodal burden.
Measured: 24 months
Patients with ≤2 nodal metastases identified on histology.
To determine the number of patients with fewer than 3 nodal metastases on final histology, and assess whether ultrasound-detected abnormal nodes and tumour characteristics can predict axillary nodal burden.
Measured: 36 months
Patients with ≤2 nodal metastases identified on histology.
To determine the number of patients with fewer than 3 nodal metastases on final histology, and assess whether ultrasound-detected abnormal nodes and tumour characteristics can predict axillary nodal burden.
Measured: 48 months
Patients with ≤2 nodal metastases identified on histology.
To determine the number of patients with fewer than 3 nodal metastases on final histology, and assess whether ultrasound-detected abnormal nodes and tumour characteristics can predict axillary nodal burden.
Measured: 60 months
Identification rate of marked node
Identification rate of marked biopsied node at axillary surgery
Measured: 12 months
Identification rate of marked node
Identification rate of marked biopsied node at axillary surgery
Measured: 24 months
Identification rate of marked node
Identification rate of marked biopsied node at axillary surgery
Measured: 36 months
Identification rate of marked node
Identification rate of marked biopsied node at axillary surgery
Measured: 48 months
Identification rate of marked node
Identification rate of marked biopsied node at axillary surgery
Measured: 60 months
False negative rate of targeted sentinel node biopsy
False negative rate of targeted sentinel node biopsy (FN/TP+FN)
Measured: 12 months
False negative rate of targeted sentinel node biopsy
False negative rate of targeted sentinel node biopsy (FN/TP+FN)
Measured: 24 months
False negative rate of targeted sentinel node biopsy
False negative rate of targeted sentinel node biopsy (FN/TP+FN)
Measured: 36 months
False negative rate of targeted sentinel node biopsy
False negative rate of targeted sentinel node biopsy (FN/TP+FN)
Measured: 48 months
False negative rate of targeted sentinel node biopsy
False negative rate of targeted sentinel node biopsy (FN/TP+FN)
Measured: 60 months
Arm lymphoedema
Arm lymphoedema self reported by the patient or identified during routine care, resulting in referral to a lymphoedema clinic.
Measured: 12 months
Arm lymphoedema
Arm lymphoedema self reported by the patient or identified during routine care, resulting in referral to a lymphoedema clinic.
Measured: 24 months
Arm lymphoedema
Arm lymphoedema self reported by the patient or identified during routine care, resulting in referral to a lymphoedema clinic.
Measured: 36 months
Arm lymphoedema
Arm lymphoedema self reported by the patient or identified during routine care, resulting in referral to a lymphoedema clinic.
Measured: 48 months
Arm lymphoedema
Arm lymphoedema self reported by the patient or identified during routine care, resulting in referral to a lymphoedema clinic.
Measured: 60 months
Secondary outcomes (25)
Axillary recurrence
Axillary recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrence in lymph nodes draining the primary tumour site, i.e. nodes in the ipsilateral axilla, infraclavicular fossa, supraclavicular fossa and interpectoral area. The date of axillary recurrence is the date on which imaging or pathology report (whichever comes first) confirms axillary recurrence.
Measured: 12 months
Axillary recurrence
Axillary recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrence in lymph nodes draining the primary tumour site, i.e. nodes in the ipsilateral axilla, infraclavicular fossa, supraclavicular fossa and interpectoral area. The date of axillary recurrence is the date on which imaging or pathology report (whichever comes first) confirms axillary recurrence.
Measured: 24 months
Axillary recurrence
Axillary recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrence in lymph nodes draining the primary tumour site, i.e. nodes in the ipsilateral axilla, infraclavicular fossa, supraclavicular fossa and interpectoral area. The date of axillary recurrence is the date on which imaging or pathology report (whichever comes first) confirms axillary recurrence.
Measured: 36 months
Axillary recurrence
Axillary recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrence in lymph nodes draining the primary tumour site, i.e. nodes in the ipsilateral axilla, infraclavicular fossa, supraclavicular fossa and interpectoral area. The date of axillary recurrence is the date on which imaging or pathology report (whichever comes first) confirms axillary recurrence.
Measured: 48 months
Axillary recurrence
Axillary recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrence in lymph nodes draining the primary tumour site, i.e. nodes in the ipsilateral axilla, infraclavicular fossa, supraclavicular fossa and interpectoral area. The date of axillary recurrence is the date on which imaging or pathology report (whichever comes first) confirms axillary recurrence.
Measured: 60 months
Regional (nodal) recurrence
Regional (nodal) recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrent tumour in the lymph nodes in the ipsilateral axilla, infraclavicular, supraclavicular fossa, interpectoral area or ipsilateral internal mammary chain. The date of regional recurrence is the date on which the imaging or pathology report (whichever comes first) confirms local recurrence.
Measured: 12 months
Regional (nodal) recurrence
Regional (nodal) recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrent tumour in the lymph nodes in the ipsilateral axilla, infraclavicular, supraclavicular fossa, interpectoral area or ipsilateral internal mammary chain. The date of regional recurrence is the date on which the imaging or pathology report (whichever comes first) confirms local recurrence.
Measured: 24 months
Regional (nodal) recurrence
Regional (nodal) recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrent tumour in the lymph nodes in the ipsilateral axilla, infraclavicular, supraclavicular fossa, interpectoral area or ipsilateral internal mammary chain. The date of regional recurrence is the date on which the imaging or pathology report (whichever comes first) confirms local recurrence.
Measured: 36 months
Regional (nodal) recurrence
Regional (nodal) recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrent tumour in the lymph nodes in the ipsilateral axilla, infraclavicular, supraclavicular fossa, interpectoral area or ipsilateral internal mammary chain. The date of regional recurrence is the date on which the imaging or pathology report (whichever comes first) confirms local recurrence.
Measured: 48 months
Regional (nodal) recurrence
Regional (nodal) recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrent tumour in the lymph nodes in the ipsilateral axilla, infraclavicular, supraclavicular fossa, interpectoral area or ipsilateral internal mammary chain. The date of regional recurrence is the date on which the imaging or pathology report (whichever comes first) confirms local recurrence.
Measured: 60 months
Disease free survival
Disease-Free Survival (DFS); defined and calculated as the time from targeted sentinel node biopsy until the date of first event of either a loco-regional invasive breast cancer relapse, distant relapse, ipsilateral or contralateral new invasive primary breast cancer or death by any cause or the censor date.
Measured: 12 months
Disease free survival
Disease-Free Survival (DFS); defined and calculated as the time from targeted sentinel node biopsy until the date of first event of either a loco-regional invasive breast cancer relapse, distant relapse, ipsilateral or contralateral new invasive primary breast cancer or death by any cause or the censor date.
Measured: 24 months
Disease free survival
Disease-Free Survival (DFS); defined and calculated as the time from targeted sentinel node biopsy until the date of first event of either a loco-regional invasive breast cancer relapse, distant relapse, ipsilateral or contralateral new invasive primary breast cancer or death by any cause or the censor date.
Measured: 36 months
Disease free survival
Disease-Free Survival (DFS); defined and calculated as the time from targeted sentinel node biopsy until the date of first event of either a loco-regional invasive breast cancer relapse, distant relapse, ipsilateral or contralateral new invasive primary breast cancer or death by any cause or the censor date.
Measured: 48 months
Disease free survival
Disease-Free Survival (DFS); defined and calculated as the time from targeted sentinel node biopsy until the date of first event of either a loco-regional invasive breast cancer relapse, distant relapse, ipsilateral or contralateral new invasive primary breast cancer or death by any cause or the censor date.
Measured: 60 months
Overall survival
Overall survival; calculated as the time from targeted sentinel node biopsy until the date of death by any cause or the censor date.
Measured: 12 months
Overall survival
Overall survival; calculated as the time from targeted sentinel node biopsy until the date of death by any cause or the censor date.
Measured: 24 months
Overall survival
Overall survival; calculated as the time from targeted sentinel node biopsy until the date of death by any cause or the censor date.
Measured: 36 months
Overall survival
Overall survival; calculated as the time from targeted sentinel node biopsy until the date of death by any cause or the censor date.
Measured: 48 months
Overall survival
Overall survival; calculated as the time from targeted sentinel node biopsy until the date of death by any cause or the censor date.
Measured: 60 months
Local (breast or chest wall) recurrence
Local (breast or chest wall) recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrence after mastectomy in the skin or soft tissue of the chest wall within the anatomical area bounded by the mid-sternal line, the clavicle, the posterior axillary line and the costal margin or any type of breast carcinoma in the breast after conservation therapy. The date of local recurrence is the date on which the imaging or pathology report (whichever comes first) confirms local recurrence.
Measured: 12 months
Local (breast or chest wall) recurrence
Local (breast or chest wall) recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrence after mastectomy in the skin or soft tissue of the chest wall within the anatomical area bounded by the mid-sternal line, the clavicle, the posterior axillary line and the costal margin or any type of breast carcinoma in the breast after conservation therapy. The date of local recurrence is the date on which the imaging or pathology report (whichever comes first) confirms local recurrence.
Measured: 24 months
Local (breast or chest wall) recurrence
Local (breast or chest wall) recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrence after mastectomy in the skin or soft tissue of the chest wall within the anatomical area bounded by the mid-sternal line, the clavicle, the posterior axillary line and the costal margin or any type of breast carcinoma in the breast after conservation therapy. The date of local recurrence is the date on which the imaging or pathology report (whichever comes first) confirms local recurrence.
Measured: 36 months
Local (breast or chest wall) recurrence
Local (breast or chest wall) recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrence after mastectomy in the skin or soft tissue of the chest wall within the anatomical area bounded by the mid-sternal line, the clavicle, the posterior axillary line and the costal margin or any type of breast carcinoma in the breast after conservation therapy. The date of local recurrence is the date on which the imaging or pathology report (whichever comes first) confirms local recurrence.
Measured: 48 months
Local (breast or chest wall) recurrence
Local (breast or chest wall) recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrence after mastectomy in the skin or soft tissue of the chest wall within the anatomical area bounded by the mid-sternal line, the clavicle, the posterior axillary line and the costal margin or any type of breast carcinoma in the breast after conservation therapy. The date of local recurrence is the date on which the imaging or pathology report (whichever comes first) confirms local recurrence.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start17 Jan 2025
- Primary completionDec 2033 (estimated)
- Study completionDec 2033 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Amit Goyal, University Hospitals of Derby and Burton NHS Foundation Trust
- Investigators
- Amit Goyal, Study chair, University Hospitals of Derby and Burton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085442
- Sponsor's protocol ID
- PID 46
- Acronym
- NodeSMART
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NodeSMART - Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
- ClinicalTrials.gov ID
- NCT07085442
- Acronym / sponsor ID
- NodeSMART / PID 46
- Conditions
- Breast Cancer, Axillary Lymph Nodes Dissection, Axillary Metastases, Sentinel Lymph Node Biopsy (SLNB), Node Positive Breast Cancer, Axilla; Breast
- Keywords
- Targeted Axillary Dissection, Targeted Sentinel Node Biopsy, NodeSMART, Breast Cancer, Sentinel Node Biopsy, Axillary Lymph Nodes Dissection, Axillary Node Clearance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- Dec 2033 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 25 Jul 2025 (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.
Axillary ultrasound scan (AUS) is routinely employed in the UK for preoperative axillary staging and can diagnose approximately 50 - 80% of node positive patients when combined with percutaneous needle biopsy techniques (either core-biopsy or fine-needle aspiration cytology). It is recognised that nodal burden is generally higher in clinically node negative patients with abnormal nodes on AUS and confirmed on needle-biopsy to be histologically positive than patients diagnosed as node positive on sentinel node biopsy (SNB). However, up to 40% of biopsy-proven node positive patients are found to have fewer than 3 involved nodes on subsequent axillary lymph node dissection (ALND) and are potential candidates for less extensive axillary surgery with axillary radiotherapy (ART) rather than ALND. The total number of abnormal nodes on ultrasound is a key predictor of overall nodal tumour burden.
The AMAROS and OTOASOR trials randomised patients with up to 2 positive sentinel nodes to either ALND or ART. These trials were conducted around the turn of the millennium and before routine use of AUS and therefore would have included a significant number of patients who were radiologically node positive (cN1). Likewise, the ACOSOG Z0011 trial that randomised a similar group of patients to either ALND or observation only, did not incorporate routine AUS and would have included some (radiological) cN1 patients. These trials revealed no adverse impact on disease-free or overall survival from omission of completion ALND.
Targeted axillary dissection (TAD) was introduced a few years ago to reduce the false negative rate of SNB following neoadjuvant chemotherapy (NACT) and has been standardised as part of the ongoing ATNEC trial [ClinicalTrials.govNCT04109079]. This technique for axillary staging after NACT is increasingly being adopted in the UK and elsewhere. TAD is technically more straightforward and less challenging in patients undergoing primary surgery with no concerns about clip migration consequent to nodal shrinkage as part of treatment response to NACT. Furthermore, the risk of under-treating the axilla is offset by the protocol: if no disease is identified in the targeted nodes (false-negative case), then patients proceed to ALND, thereby ensuring adequate treatment. Unlike TAD following NACT, the presence of viable tumour within the sampled nodes is mandatory and finding fibrosis is irrelevant except as a response to nodal biopsy per se.
Current ASCO guidelines support both SNB and TAD as staging options for patients with ultrasound-detected, biopsy-confirmed nodal disease. The Edinburgh randomised trials comparing four-node sampling with ALND demonstrated significantly lower arm morbidity with node sampling, supporting TAD as a less morbid appropriate alternative in this patient population.
The UK-ANZ POSNOC trial randomised 1,900 patients with <3 macrometastases to either no further axillary treatment or additional axillary treatment. The study included cN1 patients with biopsy-confirmed nodal metastases who underwent sentinel node biopsy or TAD. Patients with <3 macrometastases on final histology were randomised to receive no further axillary treatment or proceed with additional axillary treatment (ALND or ART). POSNOC trial will answer whether further axillary treatment provides any benefit in patients with low volume nodal disease on SNB or TAD.
Notably, patients with biopsy-confirmed metastases and <3 macrometastases on SNB/TAD are biologically and clinically similar to patients with normal AUS who are later found to have low-volume disease on SNB. Clinical decision-making and patient outcomes are driven by tumour biology and overall disease burden rather than the method of nodal disease detection. Furthermore, AUS sensitivity is operator dependent and whether FNA or core biopsy was used to sample the node. A patient considered node negative on AUS by one radiologist may be diagnosed with core biopsy confirmed nodal metastases with another radiologist. Pending the results of POSNOC trial, patients with less than 3 macrometastases are generally advised further axillary treatment, and ART is preferred over ALND to reduce the risk of lymphoedema.
NodeSMART is a prospective audit collecting data on patients undergoing TAD in the primary surgery setting. Its goal is to audit surgical outcomes and benchmark them against - a) Comparing technical outcomes with those from sentinel node biopsy in the primary surgery setting and TAD performed after neoadjuvant chemotherapy. b) Assessing rates of arm lymphoedema and disease progression relative to findings from the AMAROS and Z11 trials, and the POSNOC trial once results are available. The term "Targeted Axillary Dissection" is somewhat misleading in this context, as the marked (biopsied) node is removed alongside sentinel nodes - not in isolation. NodeSMART therefore refers to the procedure more accurately as Targeted Sentinel Node Biopsy (TSNB).
Detailed description
Guidelines for node marking:
Node marking is required for NodeSMART. Sites are advised to follow the the best practice node marking standards used in the ongoing ATNEC breast cancer trial. At least three nodes should be removed to allow adequate assessment of nodal tumour burden.
Timing:
The node may be marked at the time of needle biopsy or at a separate visit.
Technique:
Node may be marked using any technique e.g. clip or coil (with or without skin mark), black dye, magnetic seeds or reflector.
If the marked node is not identified or less than three nodes are found on histology, patient will remain in NodeSMART. The decision regarding any further axillary treatment will be made by the treating MDT and recorded in the audit.
Single vs multiple node marking:
It is not necessary to mark more than one node, even if multiple nodes are biopsied or appear malignant. The most abnormal-appearing node should be marked.
Post TSNB axillary treatment:
Further axillary treatment following TSNB will be decided by the treating MDT as per local protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with biopsy proven nodal metastases (cN1) and not receiving neoadjuvant chemotherapy | – | Procedure: Targeted Sentinel Node Biopsy (TSNB)Patients with T1 or T2 tumours at presentation with biopsy proven nodal metastases (cN1) and with ≤2 abnormal nodes on axillary ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cT1-2N1M0 breast cancer patients aged 18 years or older, with needle biopsy proven nodal metastases, ≤2 abnormal nodes on imaging, and are undergoing sentinel node biopsy and removal of the marked involved node.
Key inclusion criteria (8 listed)
- cT1-2N1M0 breast cancer*
- FNA or core biopsy confirmed axillary nodal metastases
- ≤2 abnormal nodes on imaging
- The biopsied involved node should be marked using any technique
- Undergo a dual tracer or single tracer sentinel node biopsy with removal of the marked node (Targeted Sentinel Node Biopsy, TSNB)‡
Key exclusion criteria (5 listed)
- Neoadjuvant chemotherapy†
- Previous ipsilateral axillary lymph node dissection
- cT3-4 breast cancer
- ≥3 abnormal nodes on imaging
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 |
|---|---|---|
| Targeted Sentinel Node Biopsy (TSNB)Targeted Sentinel Node Biopsy will be performed according to routine local practice. The procedure has been standardised for the post-NACT setting as part of the ongoing ATNEC trial. Sites are advised to follow the ATNEC protocol in the primary surgery setting, using either a dual- or single-tracer sentinel node biopsy technique, with localisation and removal of the marked biopsy proven positive node, and removal of at least 3 nodes. Axillary treatment following TSNB will be determined according to local MDT recommendations. | Procedure or surgery | Patients with biopsy proven nodal metastases (cN1) and not receiving neoadjuvant chemotherapy |
Primary outcome
Patients with ≤2 nodal metastases identified on histology.
Time frame: 12 months
To determine the number of patients with fewer than 3 nodal metastases on final histology, and assess whether ultrasound-detected abnormal nodes and tumour characteristics can predict axillary nodal burden.
Patients with ≤2 nodal metastases identified on histology.
Time frame: 24 months
To determine the number of patients with fewer than 3 nodal metastases on final histology, and assess whether ultrasound-detected abnormal nodes and tumour characteristics can predict axillary nodal burden.
Patients with ≤2 nodal metastases identified on histology.
Time frame: 36 months
To determine the number of patients with fewer than 3 nodal metastases on final histology, and assess whether ultrasound-detected abnormal nodes and tumour characteristics can predict axillary nodal burden.
Patients with ≤2 nodal metastases identified on histology.
Time frame: 48 months
To determine the number of patients with fewer than 3 nodal metastases on final histology, and assess whether ultrasound-detected abnormal nodes and tumour characteristics can predict axillary nodal burden.
Patients with ≤2 nodal metastases identified on histology.
Time frame: 60 months
To determine the number of patients with fewer than 3 nodal metastases on final histology, and assess whether ultrasound-detected abnormal nodes and tumour characteristics can predict axillary nodal burden.
Identification rate of marked node
Time frame: 12 months
Identification rate of marked biopsied node at axillary surgery
Identification rate of marked node
Time frame: 24 months
Identification rate of marked biopsied node at axillary surgery
Identification rate of marked node
Time frame: 36 months
Identification rate of marked biopsied node at axillary surgery
Identification rate of marked node
Time frame: 48 months
Identification rate of marked biopsied node at axillary surgery
Identification rate of marked node
Time frame: 60 months
Identification rate of marked biopsied node at axillary surgery
False negative rate of targeted sentinel node biopsy
Time frame: 12 months
False negative rate of targeted sentinel node biopsy (FN/TP+FN)
False negative rate of targeted sentinel node biopsy
Time frame: 24 months
False negative rate of targeted sentinel node biopsy (FN/TP+FN)
False negative rate of targeted sentinel node biopsy
Time frame: 36 months
False negative rate of targeted sentinel node biopsy (FN/TP+FN)
False negative rate of targeted sentinel node biopsy
Time frame: 48 months
False negative rate of targeted sentinel node biopsy (FN/TP+FN)
False negative rate of targeted sentinel node biopsy
Time frame: 60 months
False negative rate of targeted sentinel node biopsy (FN/TP+FN)
Arm lymphoedema
Time frame: 12 months
Arm lymphoedema self reported by the patient or identified during routine care, resulting in referral to a lymphoedema clinic.
Arm lymphoedema
Time frame: 24 months
Arm lymphoedema self reported by the patient or identified during routine care, resulting in referral to a lymphoedema clinic.
Arm lymphoedema
Time frame: 36 months
Arm lymphoedema self reported by the patient or identified during routine care, resulting in referral to a lymphoedema clinic.
Arm lymphoedema
Time frame: 48 months
Arm lymphoedema self reported by the patient or identified during routine care, resulting in referral to a lymphoedema clinic.
Arm lymphoedema
Time frame: 60 months
Arm lymphoedema self reported by the patient or identified during routine care, resulting in referral to a lymphoedema clinic.
25 secondary outcomes
Axillary recurrence
Time frame: 12 months
Axillary recurrence
Time frame: 24 months
Axillary recurrence
Time frame: 36 months
Axillary recurrence
Time frame: 48 months
Axillary recurrence
Time frame: 60 months
Regional (nodal) recurrence
Time frame: 12 months
Regional (nodal) recurrence
Time frame: 24 months
Regional (nodal) recurrence
Time frame: 36 months
Regional (nodal) recurrence
Time frame: 48 months
Regional (nodal) recurrence
Time frame: 60 months
Disease free survival
Time frame: 12 months
Disease free survival
Time frame: 24 months
Disease free survival
Time frame: 36 months
Disease free survival
Time frame: 48 months
Disease free survival
Time frame: 60 months
Overall survival
Time frame: 12 months
Overall survival
Time frame: 24 months
Overall survival
Time frame: 36 months
Overall survival
Time frame: 48 months
Overall survival
Time frame: 60 months
Local (breast or chest wall) recurrence
Time frame: 12 months
Local (breast or chest wall) recurrence
Time frame: 24 months
Local (breast or chest wall) recurrence
Time frame: 36 months
Local (breast or chest wall) recurrence
Time frame: 48 months
Local (breast or chest wall) recurrence
Time frame: 60 months
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 3 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Amit Goyal study chair
University Hospitals of Derby and Burton NHS Foundation Trust
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Axillary Lymph Nodes Dissection, run by University Hospitals of Derby and Burton NHS Foundation Trust at 14 sites in United Kingdom.
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 5 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom. 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 Amit Goyal (01332 786958, amit.goyal@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with ≤2 nodal metastases identified on histology. (time frame: 12 months). The study lists 20 primary outcomes in all. 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 3 Nov 2026.