Breast Cancer InvasiveNCT07283718
The Association Between Axillary Lymph Node Metastasis Patterns and Breast Cancer Prognosis
An observational study of Breast Cancer Invasive, run by Wenjin Yin at 1 site in China.
Trial summary
This is a real-world multicentre study to investigate the metastatic pattern of axillary lymph node and its association with breast cancer prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Invasive
- What is being tested?
- ALND
- Type of treatment
- Surgery or procedure
- How many people
- 2,467 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2025to 28 Sep 2026
- 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: Patients were pathologically diagnosed primary invasive breast cancer from October 2013 to December 2023. They had axillary lymph node dissection.
Who may be able to join
- Aged 18 years or older
- Pathologically confirmed invasive primary breast cancer
Who cannot join
- De novo stage IV breast cancer
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, 200127
About this study
Official title: The Association Between Axillary Lymph Node Metastasis Patterns and Breast Cancer Prognosis：a Real-world Study
This is a real-world multicentre study to investigate the metastatic pattern of axillary lymph node and its association with breast cancer prognosis.
- Conditions
- Breast Cancer Invasive
- Being tested
- ALND
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALNDProcedure or surgery
axillary lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| ALND | breast cancer patients receiving axillary lymph mode dissection Receives: Procedure: ALND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Disease-free survival time is defined as the time from the date of axillary lymph node dissection until the date of the first occurrence of local/regional relapse, distant recurrence, contralateral breast cancer, second malignancy and death from any cause.
Measured: From the date of axillary lymph node dissection until time of event up to 3 years
Secondary outcomes (2)
Recurrence-free survival
Recurrence-free survival time is defined as the time from the date of axillary lymph node dissection until the date of the first occurrence of local/regional recurrence, distant recurrence and death from any cause
Measured: From the date of axillary lymph node dissection until time of event up to 3 years
Overall survival
Overall survival time is defined as the time from the date of axillary lymph node dissection until death from any cause
Measured: From the date of axillary lymph node dissection until time of event up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start28 Sep 2025
- Primary completion11 Oct 2025
- Study completion28 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer InvasiveStudies 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
- Retrospective
- Enrolment
- 2,467 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenjin Yin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wenjin Yin, RenJi Hospital
- Investigators
- Wenjin Yin, M.D., Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283718
- Sponsor's protocol ID
- LY2025-298-B
- Status last verified
- May 2026
- First submitted
- 4 Dec 2025
- Last updated
- 13 May 2026
- 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Axillary Lymph Node Metastasis Patterns and Breast Cancer Prognosis：a Real-world Study
- ClinicalTrials.gov ID
- NCT07283718
- Acronym / sponsor ID
- LY2025-298-B
- Conditions
- Breast Cancer Invasive
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,467 participants (estimated)
- Lead sponsor
- Wenjin YinUniversity, hospital or other
- Study start
- 28 Sep 2025 (actual)
- Primary completion
- 11 Oct 2025 (actual)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 16 Dec 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.
This is a real-world multicentre study to investigate the metastatic pattern of axillary lymph node and its association with breast cancer prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALND | – | Procedure: ALNDbreast cancer patients receiving axillary lymph mode dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were pathologically diagnosed primary invasive breast cancer from October 2013 to December 2023. They had axillary lymph node dissection.
Key inclusion criteria (2 listed)
- Aged 18 years or older
- Pathologically confirmed invasive primary breast cancer
Key exclusion criteria (1 listed)
- De novo stage IV 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 |
|---|---|---|
| ALNDaxillary lymph node dissection | Procedure or surgery | ALND |
Primary outcome
Disease free survival
Time frame: From the date of axillary lymph node dissection until time of event up to 3 years
Disease-free survival time is defined as the time from the date of axillary lymph node dissection until the date of the first occurrence of local/regional relapse, distant recurrence, contralateral breast cancer, second malignancy and death from any cause.
2 secondary outcomes
Recurrence-free survival
Time frame: From the date of axillary lymph node dissection until time of event up to 3 years
Overall survival
Time frame: From the date of axillary lymph node dissection until time of event up to 3 years
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 13 May 2026.
Related trials for Breast Cancer Invasive
RecruitingPhase 1
A Study of 68Ga-FAPI Breast PET/MRI Scans in People With Breast Cancer
Breast Cancer, Invasive Breast Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1/2
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
Colorectal Cancer, Epithelial Ovarian Cancer
Active, not recruitingPhase 3
Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer
Breast Cancer Invasive, Hormone-receptor-positive Breast Cancer
RecruitingPhase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
Metastatic Breast Cancer, Leptomeningeal Disease
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.
Wenjin Yin, M.D. principal investigator
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
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 Invasive, run by Wenjin Yin 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 2 inclusion and 1 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 13 May 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?
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?
Disease free survival (time frame: From the date of axillary lymph node dissection until time of event up to 3 years). 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 13 May 2026.