Neoplasm, BreastNCT03715686
To Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes
A study testing wire localization in people with Neoplasm, Breast and Neoadjuvant Chemotherapy, run by Peking University at 1 site in China.
Trial summary
The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in clinical stage N1 (cN1) breast cancer patients. Accuracy of sentinel lymph node biopsy (SLNB) alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Neoplasm, Breast, Neoadjuvant Chemotherapy, Lymph Node Metastases
- What is being tested?
- wire localization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the age of 18 and 65
- Eastern Cooperative Oncology Group (ECOG) score 0 or 1
- pathologically proven positive axillary lymph node
- enough renal and liver function to sustain chemotherapy
- informed consent obtained
Who cannot join
- inflammatory breast cancer
- being pregnant or nursing
- neoadjuvant chemotherapy not planned
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital Breast Center
Beijing
About this study
Official title: To Accurately Assess Lymph Node Response to Neoadjuvant Chemotherapy by Wire Localization of Clip-marked Axillary Lymph Nodes in Breast Cancer Patients
The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in clinical stage N1 (cN1) breast cancer patients. Accuracy of sentinel lymph node biopsy (SLNB) alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. New model to predict lymph node pathological complete remission (pCR) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients is sought for.
Read the detailed description
The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in cN1 breast cancer patients. In brief, pathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy (NACT) and continuously monitored through out the course of chemotherapy with ultrasound. After the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. During surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. Axillary lymph node dissection (ALND) will be performed in all participants. Accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. Axillary ultrasound and CT scan will be performed before and after neoadjuvant chemotherapy for all patients enrolled. By assessing clinical-pathological and imaging data acquired from this trial, the investigator look forward to developing a model to accurately predict lymph node pCR (AUC >0.85) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients.
- Being tested
- wire localization
- Keywords
- Neoplasm, Breast, neoadjuvant chemotherapy, Lymph Node Metastases, response
- Medical subject headings
- Breast Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wire localizationProcedure or surgery
Pathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy. After the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. During surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. ALND will be performed in all participants.
| Study group | Role | What they receive |
|---|---|---|
| Wire localization | Experimental | Intervention: procedure: wire localization Receives: Procedure: wire localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes.
Sensitivity, specificity, false negative rate and negative predictive value will be calculated.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Model to predict lymph node pCR in cN1 patients.
Using clinical pathological and image data collected, generate a model to predict lymph node pCR in cN1 patients.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start20 Oct 2018
- Primary completion20 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasm, BreastStudies 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
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao OUYANG, Peking University Cancer Hospital & Institute
- Investigators
- Tao Ouyang, Dr., Study director, Beijing Cancer Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715686
- Sponsor's protocol ID
- BCP24
- Status last verified
- Sep 2021
- First submitted
- 13 Oct 2018
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Zheng Q, He Y, Liu Y, Huo L, Zhang N, Wang T, Xie Y, Li J, Ouyang T, Fan Z. Diagnostic accuracy of sentinel lymph node biopsy and wire localized clipped node biopsy after neoadjuvant chemotherapy in node-positive breast cancer. Surg Today. 2025 Feb;55(2):172-179. doi: 10.1007/s00595-024-02981-0. Epub 2024 Dec 27.
PubMed 39725764
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Accurately Assess Lymph Node Response to Neoadjuvant Chemotherapy by Wire Localization of Clip-marked Axillary Lymph Nodes in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03715686
- Acronym / sponsor ID
- BCP24
- Keywords
- Neoplasm, Breast, neoadjuvant chemotherapy, Lymph Node Metastases, response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 20 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 23 Oct 2018 (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 investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in clinical stage N1 (cN1) breast cancer patients. Accuracy of sentinel lymph node biopsy (SLNB) alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. New model to predict lymph node pathological complete remission (pCR) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients is sought for.
Detailed description
The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in cN1 breast cancer patients. In brief, pathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy (NACT) and continuously monitored through out the course of chemotherapy with ultrasound. After the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. During surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. Axillary lymph node dissection (ALND) will be performed in all participants. Accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. Axillary ultrasound and CT scan will be performed before and after neoadjuvant chemotherapy for all patients enrolled. By assessing clinical-pathological and imaging data acquired from this trial, the investigator look forward to developing a model to accurately predict lymph node pCR (AUC >0.85) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wire localization | Experimental | Procedure: wire localizationIntervention: procedure: wire localization |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- between the age of 18 and 65
- Eastern Cooperative Oncology Group (ECOG) score 0 or 1
- pathologically proven positive axillary lymph node
- enough renal and liver function to sustain chemotherapy
- informed consent obtained
Key exclusion criteria (3 listed)
- inflammatory breast cancer
- being pregnant or nursing
- neoadjuvant chemotherapy not planned
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 |
|---|---|---|
| wire localizationPathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy. After the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. During surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. ALND will be performed in all participants. | Procedure or surgery | Wire localization |
Primary outcome
The accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes.
Time frame: through study completion, an average of 1 year
Sensitivity, specificity, false negative rate and negative predictive value will be calculated.
1 secondary outcome
Model to predict lymph node pCR in cN1 patients.
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Derived from this study: PubMed 39725764Wang X, Zheng Q, He Y, Liu Y, Huo L, Zhang N, Wang T, Xie Y, Li J, Ouyang T, Fan Z. Diagnostic accuracy of sentinel lymph node biopsy and wire localized clipped node biopsy after neoadjuvant chemotherapy in node-positive breast cancer. Surg Today. 2025 Feb;55(2):172-179. doi: 10.1007/s00595-024-02981-0. Epub 2024 Dec 27.
- 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.
Tao Ouyang, Dr. study director
Beijing Cancer Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wire localization in people with Neoplasm, Breast and Neoadjuvant Chemotherapy, run by Peking University 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Nov 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinguang Wang, Dr. (+86 88271119 ext. 4002, doctorwxg79@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes. (time frame: through study completion, an average of 1 year). 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 NCT03715686, which also lists 1 linked publication.
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 29 Nov 2021.