Breast CancerNCT07791771
SLNB Combined With WLNB for Axillary De-escalation in Breast Cancer Patients With Abnormal Axillary Nodes
An observational study of Breast Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This prospective observational diagnostic study aims to evaluate the feasibility of using sentinel lymph node biopsy combined with wire localized lymph node biopsy (SLNB+WLNB) to identify breast cancer patients with 1-2 sonographically abnormal axillary lymph nodes who may safely avoid axillary lymph node dissection… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2026to 31 Dec 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This prospective observational cohort study will enroll female patients with invasive breast cancer who have clinically node-negative axilla on physical examination, but 1-2 abnormal axillary lymph nodes detected by ultrasound and confirmed metastatic by biopsy. Eligible patients will have cT1-2 breast cancer without distant metastasis and will undergo sentinel lymph node biopsy combined with wire localized lymph node biopsy. A total of 84 patients will be included.
Who may be able to join
- Female patients pathologically confirmed with primary invasive breast cancer via core needle biopsy;
- Aged 18 years or older;
- No enlarged lymph nodes palpable in the axilla on clinical examination; ultrasound reveals 1 or 2 abnormal ipsilateral axillary lymph nodes with malignant features (cortical thickening >3 mm, hypoechoic, etc.), and at least one of them is confirmed metastatic by biopsy;
- Maximum diameter of breast tumor ≤5 cm (cT1-2);
- No distant metastasis detected on tumor staging examinations;
- No prior neoadjuvant therapy received;
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- Sentinel lymph node biopsy combined with wire-localized lymph node biopsy completed by attending physicians per routine clinical practice;
- Patients meet one of the following criteria for combined lymph node biopsy results and surgical management: total number of positive lymph nodes is 1-2 with breast-conserving surgery and omission of axillary lymph node dissection; or total number of positive lymph nodes is 1-2 with modified radical mastectomy; or total number of positive lymph nodes exceeds 2, with axillary lymph node dissection performed regardless of breast-conserving surgery or total mastectomy;
- Voluntarily participating in this observational study and signing an informed consent form.
Who cannot join
- Bilateral breast cancer;
- Stage IV breast cancer;
- Receipt of neoadjuvant therapy prior to surgery;
- Previous ipsilateral axillary surgery history (e.g., osmidrosis surgery, lymph node biopsy) and history of axillary radiotherapy;
- Coexistence of other malignant tumors within the past 5 years, excluding cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.;
- Pregnant or lactating women;
- Severe cardiac and pulmonary insufficiency precluding surgical tolerance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Cancer Hospital
Beijing, 100142
Zhaoqing Fan, MD, 0086-10-88197838, zhqfan@bjmu.edu.cn
About this study
Official title: Prospective Evaluation of Sentinel Lymph Node Biopsy Combined With Wire Localized Lymph Node Biopsy for Omitting Axillary Lymph Node Dissection in Breast Cancer Patients With 1-2 Sonographically Abnormal Lymph Nodes: A Diagnostic Study
This prospective observational diagnostic study aims to evaluate the feasibility of using sentinel lymph node biopsy combined with wire localized lymph node biopsy (SLNB+WLNB) to identify breast cancer patients with 1-2 sonographically abnormal axillary lymph nodes who may safely avoid axillary lymph node dissection (ALND). A total of 84 patients with clinically node-negative, cT1-2 invasive breast cancer and biopsy-proven axillary lymph node metastasis will be enrolled. The primary endpoint is the proportion of patients with total positive lymph nodes ≤2 after SLNB+WLNB.
Read the detailed description
Axillary surgery in breast cancer has evolved toward individualized and less invasive approaches. However, the optimal axillary management remains controversial for patients with clinically node-negative disease but abnormal axillary lymph nodes detected by ultrasound and confirmed metastatic by biopsy.
This prospective cohort study will evaluate whether SLNB combined with WLNB can accurately assess axillary tumor burden and identify patients suitable for omission of ALND.
Patients will undergo SLNB and wire localized biopsy of abnormal lymph nodes according to routine clinical practice. Pathological findings will be collected and analyzed.
The study will assess the proportion of patients with ≤2 positive lymph nodes, diagnostic concordance between SLNB and WLNB, and factors associated with axillary tumor burden.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Axillary lymph node, Sentinel lymph node biopsy, Wire localized lymph node biopsy, Axillary de-escalation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SLNB + WLNB Cohort | Patients with clinically node-negative breast cancer, 1-2 abnormal axillary lymph nodes detected by ultrasound, and biopsy-confirmed axillary lymph node metastasis will undergo sentinel lymph node biopsy combined with wire localized lymph node biopsy. Clinical and pathological data will be collected prospectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients with Total Positive Lymph Nodes ≤2
To determine the proportion and 95% confidence interval of patients whose total number of positive lymph nodes after SLNB combined with WLNB is ≤2.
Measured: Perioperative
Secondary outcomes (4)
Comparison of Low Axillary Tumor Burden Between Patients with 1 vs 2 Abnormal Lymph Nodes on Ultrasound
Measured: Perioperative
Positive Rate of Wire Localized Lymph Nodes Alone
Measured: Perioperative
Concordance Between Sentinel Lymph Node and Wire Localized Lymph Node Metastasis
Measured: Perioperative
Additional Positive Lymph Nodes After Axillary Lymph Node Dissection
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiwei Wang, MD, Principal investigator, Breast Center, Peking University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791771
- Sponsor's protocol ID
- BC-P42
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study is a single-center exploratory observational study. Data will be protected according to institutional policies and applicable regulations.
Publications
Matar-Ujvary R, Sevilimedu V, Morrow M. Are Clinically Node-Negative Patients with a Positive Preoperative Axillary Lymph Node Biopsy Appropriate Candidates for Sentinel Lymph Node Biopsy? Ann Surg Oncol. 2025 Jan;32(1):92-97. doi: 10.1245/s10434-024-16321-6. Epub 2024 Oct 12.
PubMed 39394489Man V, Luk WP, Fung LH, Kwong A. The role of pre-operative axillary ultrasound in assessment of axillary tumor burden in breast cancer patients: a systematic review and meta-analysis. Breast Cancer Res Treat. 2022 Nov;196(2):245-254. doi: 10.1007/s10549-022-06699-w. Epub 2022 Sep 22.
PubMed 36138294Boyle MK, Amersi F, Chung A, Tseng J, Giuliano AE. Comparison of Targeted Axillary Dissection with Sentinel Node Biopsy Alone on Nodal Recurrence for Patients who have Node-Positive Breast Cancer Treated with Neoadjuvant Chemotherapy. Ann Surg Oncol. 2025 Jul;32(7):4847-4854. doi: 10.1245/s10434-025-17197-w. Epub 2025 Mar 25.
PubMed 40131624
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Sentinel Lymph Node Biopsy Combined With Wire Localized Lymph Node Biopsy for Omitting Axillary Lymph Node Dissection in Breast Cancer Patients With 1-2 Sonographically Abnormal Lymph Nodes: A Diagnostic Study
- ClinicalTrials.gov ID
- NCT07791771
- Acronym / sponsor ID
- BC-P42
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Axillary lymph node, Sentinel lymph node biopsy, Wire localized lymph node biopsy, Axillary de-escalation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Aug 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.
This prospective observational diagnostic study aims to evaluate the feasibility of using sentinel lymph node biopsy combined with wire localized lymph node biopsy (SLNB+WLNB) to identify breast cancer patients with 1-2 sonographically abnormal axillary lymph nodes who may safely avoid axillary lymph node dissection (ALND). A total of 84 patients with clinically node-negative, cT1-2 invasive breast cancer and biopsy-proven axillary lymph node metastasis will be enrolled. The primary endpoint is the proportion of patients with total positive lymph nodes ≤2 after SLNB+WLNB.
Detailed description
Axillary surgery in breast cancer has evolved toward individualized and less invasive approaches. However, the optimal axillary management remains controversial for patients with clinically node-negative disease but abnormal axillary lymph nodes detected by ultrasound and confirmed metastatic by biopsy.
This prospective cohort study will evaluate whether SLNB combined with WLNB can accurately assess axillary tumor burden and identify patients suitable for omission of ALND.
Patients will undergo SLNB and wire localized biopsy of abnormal lymph nodes according to routine clinical practice. Pathological findings will be collected and analyzed.
The study will assess the proportion of patients with ≤2 positive lymph nodes, diagnostic concordance between SLNB and WLNB, and factors associated with axillary tumor burden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLNB + WLNB Cohort | – | –Patients with clinically node-negative breast cancer, 1-2 abnormal axillary lymph nodes detected by ultrasound, and biopsy-confirmed axillary lymph node metastasis will undergo sentinel lymph node biopsy combined with wire localized lymph node biopsy. Clinical and pathological data will be collected prospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective observational cohort study will enroll female patients with invasive breast cancer who have clinically node-negative axilla on physical examination, but 1-2 abnormal axillary lymph nodes detected by ultrasound and confirmed metastatic by biopsy. Eligible patients will have cT1-2 breast cancer without distant metastasis and will undergo sentinel lymph node biopsy combined with wire localized lymph node biopsy. A total of 84 patients will be included.
Key inclusion criteria (9 listed)
- Female patients pathologically confirmed with primary invasive breast cancer via core needle biopsy;
- Aged 18 years or older;
- No enlarged lymph nodes palpable in the axilla on clinical examination; ultrasound reveals 1 or 2 abnormal ipsilateral axillary lymph nodes with malignant features (cortical thickening >3 mm, hypoechoic, etc.), and at least one of them is confirmed metastatic by biopsy;
- Maximum diameter of breast tumor ≤5 cm (cT1-2);
- No distant metastasis detected on tumor staging examinations;
Key exclusion criteria (7 listed)
- Bilateral breast cancer;
- Stage IV breast cancer;
- Receipt of neoadjuvant therapy prior to surgery;
- Previous ipsilateral axillary surgery history (e.g., osmidrosis surgery, lymph node biopsy) and history of axillary radiotherapy;
- Coexistence of other malignant tumors within the past 5 years, excluding cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Patients with Total Positive Lymph Nodes ≤2
Time frame: Perioperative
To determine the proportion and 95% confidence interval of patients whose total number of positive lymph nodes after SLNB combined with WLNB is ≤2.
4 secondary outcomes
Comparison of Low Axillary Tumor Burden Between Patients with 1 vs 2 Abnormal Lymph Nodes on Ultrasound
Time frame: Perioperative
Positive Rate of Wire Localized Lymph Nodes Alone
Time frame: Perioperative
Concordance Between Sentinel Lymph Node and Wire Localized Lymph Node Metastasis
Time frame: Perioperative
Additional Positive Lymph Nodes After Axillary Lymph Node Dissection
Time frame: Perioperative
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 28 Aug 2026.
- Results publication: PubMed 39394489Matar-Ujvary R, Sevilimedu V, Morrow M. Are Clinically Node-Negative Patients with a Positive Preoperative Axillary Lymph Node Biopsy Appropriate Candidates for Sentinel Lymph Node Biopsy? Ann Surg Oncol. 2025 Jan;32(1):92-97. doi: 10.1245/s10434-024-16321-6. Epub 2024 Oct 12.
- Results publication: PubMed 36138294Man V, Luk WP, Fung LH, Kwong A. The role of pre-operative axillary ultrasound in assessment of axillary tumor burden in breast cancer patients: a systematic review and meta-analysis. Breast Cancer Res Treat. 2022 Nov;196(2):245-254. doi: 10.1007/s10549-022-06699-w. Epub 2022 Sep 22.
- Results publication: PubMed 40131624Boyle MK, Amersi F, Chung A, Tseng J, Giuliano AE. Comparison of Targeted Axillary Dissection with Sentinel Node Biopsy Alone on Nodal Recurrence for Patients who have Node-Positive Breast Cancer Treated with Neoadjuvant Chemotherapy. Ann Surg Oncol. 2025 Jul;32(7):4847-4854. doi: 10.1245/s10434-025-17197-w. Epub 2025 Mar 25.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study is a single-center exploratory observational study. Data will be protected according to institutional policies and applicable regulations.
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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.
Jiwei Wang, MD principal investigator
Breast Center, Peking University Cancer Hospital
1 site 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, run by Peking University Cancer Hospital & Institute at 1 site in China.
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 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: opening soon, as of the sponsor's last update on 28 Aug 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 China. 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 Jiwei Wang, MD (0086-10-88197829, jiweiwang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients with Total Positive Lymph Nodes ≤2 (time frame: Perioperative). 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 NCT07791771, which also lists 3 linked publications.
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 28 Aug 2026.