Breast CancerNCT07428720
Axillary Lymph Node Changes After Neoadjuvant Therapy In Breast Cancer
A study testing Ultrasound Elastography in people with Breast Cancer and Axillary Lymph Node Metastasis, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study is to improve regional surgical treatment in breast cancer patients with axillary lymph node metastases (cN+) who received neoadjuvant systemic treatment (NAST) by using ultrasound elastography. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Axillary Lymph Node Metastasis
- What is being tested?
- Ultrasound Elastography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2022to 31 Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years or older
- Histologically confirmed breast cancer
- Clinically positive axillary lymph nodes before neoadjuvant systemic treatment (cN+)
- Completed neoadjuvant systemic treatment (NAST)
- Planned axillary surgery (sentinel lymph node biopsy and/or axillary lymph node dissection)
- Ability to provide written informed consent
Who cannot join
- Age < 18 years
- Male patients
- Metastatic disease at diagnosis
- Inflammatory breast cancer
- New primary breast cancer
- Bilateral breast cancer
- Pregnancy
- Previous breast or axillary surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implications Of Posttreatment Changes In Axillary Lymph Nodes And Axillary Surgical Procedure Optimization In Breast Cancer Patients After Neoadjuvant Systemic Treatment
The purpose of this study is to improve regional surgical treatment in breast cancer patients with axillary lymph node metastases (cN+) who received neoadjuvant systemic treatment (NAST) by using ultrasound elastography.
Read the detailed description
This study aims to optimize regional surgical treatment in breast cancer patients with axillary lymph node metastases (cN+) after neoadjuvant systemic treatment (NAST). Ultrasound elastography will be validated as a method for identifying metastases or regressive posttreatment changes in removed axillary lymph nodes.
- Conditions
- Breast Cancer, Axillary Lymph Node Metastasis
- Being tested
- Ultrasound Elastography
- Keywords
- Ultrasound Elastography, Axillary Lymph Nodes, Neoadjuvant Systemic Treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ElastographyDevice
Ultrasound elastography is used to assess axillary lymph nodes in order to identify metastases or regressive posttreatment changes after neoadjuvant systemic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Elastography Assessment | Experimental | Breast cancer patients with axillary lymph node metastases (cN+) after neoadjuvant systemic treatment undergo ultrasound elastography assessment to identify metastases or regressive changes in axillary lymph nodes. Receives: Device: Ultrasound Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Residual Axillary Lymph Node Metastasis After NAST
Diagnostic accuracy of intraoperative ultrasound elastography performed on excised axillary lymph nodes for detection of residual metastatic disease after neoadjuvant systemic treatment (NAST), using histopathological examination of excised lymph nodes as the reference standard. Diagnostic performance will be reported as sensitivity (%), specificity (%), positive predictive value (PPV, %), and negative predictive value (NPV, %).
Measured: Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (NAST).
Secondary outcomes (1)
Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Regressive Posttreatment Changes in Axillary Lymph Nodes After NAST
Diagnostic accuracy of intraoperative ultrasound elastography performed on excised axillary lymph nodes for detection of regressive posttreatment changes after neoadjuvant systemic treatment (NAST), using histopathological examination as the reference standard. Diagnostic performance will be reported as sensitivity (%), specificity (%), PPV (%), and NPV (%).
Measured: Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (NAST).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Sep 2022
- Primary completion1 Mar 2023
- Study completion31 Dec 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.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group study evaluating ultrasound elastography for identification of metastases or regressive changes in removed axillary lymph nodes after neoadjuvant systemic treatment.
- Masking
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428720
- Sponsor's protocol ID
- ERID-KSOPKR-0041/2022
- Other IDs
- 0120-178/2022/3
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 24 Feb 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 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications Of Posttreatment Changes In Axillary Lymph Nodes And Axillary Surgical Procedure Optimization In Breast Cancer Patients After Neoadjuvant Systemic Treatment
- ClinicalTrials.gov ID
- NCT07428720
- Acronym / sponsor ID
- ERID-KSOPKR-0041/2022
- Conditions
- Breast Cancer, Axillary Lymph Node Metastasis
- Keywords
- Ultrasound Elastography, Axillary Lymph Nodes, Neoadjuvant Systemic Treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Feb 2026 (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.
The purpose of this study is to improve regional surgical treatment in breast cancer patients with axillary lymph node metastases (cN+) who received neoadjuvant systemic treatment (NAST) by using ultrasound elastography.
Detailed description
This study aims to optimize regional surgical treatment in breast cancer patients with axillary lymph node metastases (cN+) after neoadjuvant systemic treatment (NAST). Ultrasound elastography will be validated as a method for identifying metastases or regressive posttreatment changes in removed axillary lymph nodes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group study evaluating ultrasound elastography for identification of metastases or regressive changes in removed axillary lymph nodes after neoadjuvant systemic treatment.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Elastography Assessment | Experimental | Device: Ultrasound ElastographyBreast cancer patients with axillary lymph node metastases (cN+) after neoadjuvant systemic treatment undergo ultrasound elastography assessment to identify metastases or regressive changes in axillary lymph nodes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients aged 18 years or older
- Histologically confirmed breast cancer
- Clinically positive axillary lymph nodes before neoadjuvant systemic treatment (cN+)
- Completed neoadjuvant systemic treatment (NAST)
- Planned axillary surgery (sentinel lymph node biopsy and/or axillary lymph node dissection)
Key exclusion criteria (8 listed)
- Age < 18 years
- Male patients
- Metastatic disease at diagnosis
- Inflammatory breast cancer
- New primary breast cancer
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 |
|---|---|---|
| Ultrasound ElastographyUltrasound elastography is used to assess axillary lymph nodes in order to identify metastases or regressive posttreatment changes after neoadjuvant systemic treatment. | Device | Ultrasound Elastography Assessment |
Primary outcome
Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Residual Axillary Lymph Node Metastasis After NAST
Time frame: Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (NAST).
Diagnostic accuracy of intraoperative ultrasound elastography performed on excised axillary lymph nodes for detection of residual metastatic disease after neoadjuvant systemic treatment (NAST), using histopathological examination of excised lymph nodes as the reference standard. Diagnostic performance will be reported as sensitivity (%), specificity (%), positive predictive value (PPV, %), and negative predictive value (NPV, %).
1 secondary outcome
Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Regressive Posttreatment Changes in Axillary Lymph Nodes After NAST
Time frame: Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (NAST).
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 24 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Elastography in people with Breast Cancer and Axillary Lymph Node Metastasis, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 6 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. 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 Slovenia. 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?
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?
Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Residual Axillary Lymph Node Metastasis After NAST (time frame: Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (NAST).). 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 24 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.