Breast CancerNCT05241119
Axillary Lymph Node Treatment Guided by Naocarbon Tracing After Neoadjuvant Chemotherapy
A study testing SLNB, pALND and ALND in people with Breast Cancer, run by Shengjing Hospital at 2 sites in China.
Trial summary
For patients with early breast cancer with negative axillary lymph nodes, sentinel lymph node biopsy (SLNB) can largely avoid complications such as upper limb lymphoedema caused by axillary lymph node dissection (ALND). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SLNB, pALND and ALND
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2021to 31 Oct 2028
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- invasive breast cancer confirmed by biopsy and histology;
- based on prone CT scan and Doppler ultrasound, axillary stage cN2-3;
- agree and meet the requirements for NAC;
- meet surgical requirements and agree to undergo surgery after NAC;
- the regime of NAC follows the NCCN recommendations.
Who cannot join
- previous history of breast cancer or other malignant tumors.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042
Jianyi Li, Dr., 13390127607, sjbreast@yeah.net
- Recruiting
Jianyi Li
Shenyang, Liaoning, 110042
Jianyi Li, Master, 86-18940257177, sjbreast@yeah.net
About this study
Official title: Precise Treatment of Axillary Lymph Nodes After Neoadjuvant Chemotherapy Guided by Long-term Nanocarbon Tracing: a Clinical Cohort Study
For patients with early breast cancer with negative axillary lymph nodes, sentinel lymph node biopsy (SLNB) can largely avoid complications such as upper limb lymphoedema caused by axillary lymph node dissection (ALND). Locally advanced breast cancer requires neoadjuvant chemotherapy (NAC), based on the breast cancer treatment guidelines. In addition to shrinking the primary breast lesion, NAC can reduce the stage for axillary positive lymph nodes. Therefore, in recent years clinicians have been considering SLNB for patients whose axillary lymph nodes have turned negative after NAC. After verification by the clinical trials, the current NCCN guidelines recommend that patients with T1-3N0-1 undergo SLNB after NAC, however, the false negative rate (FNR) of conventional SLNB after NAC is as high as 14%, which potentially leads to underestimation of the risk for recurrence and metastasis, insufficient adjuvant therapy, eventually affects long-term survival. Thus, how to accurately assess and treat axillary lymph nodes after NAC remains an urgent clinical question to be answered.
In recent years, a method using a metal clip to label positive lymph node before NAC has emerged in order to reduce the FNR of SLNB after NAC. Its principle is to trace the metastasized lymph node, so that the lymph node can be accurately found in the surgery, even if the lymph node is not blue-stained at the time. Apparently, this method is more suitable for small number of nodes, and inappropriate for more than two metastasized nodes.
The diameter of manocarbon particles (150nm) is between that of lymphatic capillaries (120-500nm) and capillaries (20-50 nm). With the unique macrophage phagocytosis, nanocarbon particles can remain in the lymphatic system for a long time. Using nanocarbon to label positive lymph nodes before NAC, our pilot study explored the regression of axillary lymph nodes after NAC. We found that, except for a small number of drug-resistant patients, the regression of positive lymph nodes after NAC followed a pattern of from the superior to the inferior, and from the medial to the lateral. We also found that, the worse the efficacy of NAC, the fewer black-stained nodes after NAC, suggesting long-term tracing of positive axillary lymph nodes by nanocarbon particles can guide precise treatment of axillary lymph nodes after NAC. These findings are integrated with our previous research project which investigated the spatial distribution of positive axillary lymph nodes with the intercostals brachial nerve (ICBN) as the boundary. It is proposed that low lymph node dissection below ICBN (pALND) may be a safe and efficient method reducing lymphoedema in patients with negative nodes after NAC. Prone position CT scan combined with clinical palpation of axillary lymph nodes can comprehensively evaluate axillary conditions in patients with breast cancer before surgery, and determine node metastasis accurately, and make correct clinical plans.
Read the detailed description
A total of 100 patients who are first diagnosed with breast cancer (stage N2 or N3) at the Liaoning Oncology Hospital will be recruited. Inclusive criteria: 1) Invasive breast cancer confirmed by biopsy and histology; 2) based on prone CT scan and Doppler ultrasound, axillary stage cN2-3; 3) agree and meet the requirements for NAC; 4) meet surgical requirements and agree to undergo surgery after NAC; 5) the regime of NAC follows the NCCN recommendations. Exclusive criteria: previous history of breast cancer or other malignant tumors. Period of investigation: 2 years.
After informed consent is obtained, under ultrasound guidance, the metastatic lymph node with the largest diameter (> 1 cm) is selected and injected under the cortex with 0.3 ml of nanocarbon. If the cortex and medulla are difficult to distinguish, inject on the surface of the node. Patients with efficacy for NAC should complete the scheduled cycles of NAC. Alteration of NAC regime is allowed for patients whose initial NAC is inefficacious, as guided by the physicians.
Surgery is performed within four weeks after completion of the last cycle of NAC. Axillary lymph nodes are assessed using CT scan. For patients with neoadjuvant efficacy of CR and PR, axillary surgery is performed under fluorescent tracing. SLNB is performed for patients with extensive black staining nodes. Standard ALND is performed if SLN is positive. For patients with less than three black-stained nodes, pALND will be performed rather than SLNB. If axilary lynph nodes under the ICBN are proved positive by frozen histology, ALND is then performed. For those with neoadjuvant efficacy of SD or PD, pALND will be performed if there are extensive black-stained nodes. Standard ALND will be performed if lymph nodes are positive as assessed by intraoperative frozen histology. ALND will be performed if the number of black-stained nodes is less than 3.
All the clinical information and imaging data will be securely preserved, including surgical procedure, black-stained and metastasized lymph nodes. Short-term observatory measures include axillary drainage (quantity, extubation time) and upper limb lymphatic drainage (changes in arm circumference 10cm above and below the elbow pre and post surgery. Long-term observatory measures include axillary recurrence rate and lymphoedema 3-5 years after surgery.
- Conditions
- Breast Cancer
- Being tested
- SLNB, pALND, ALND
- Keywords
- Breast cancer, neoadjuvant chemotherapy, lymph nodes, nanocarbon
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLNBProcedure or surgery
undergo fluorescence SLNB.
pALNDProcedure or surgery
undergo low axillary lymph node dissection with ICBN as the boundary
ALNDProcedure or surgery
undergo ALND
| Study group | Role | What they receive |
|---|---|---|
| SLNB Group | Experimental | undergo fluorescence SLNB Receives: Procedure: SLNB |
| pALND Group | Experimental | undergo low axillary lymph node dissection with ICBN as the boundary Receives: Procedure: pALND |
| ALND Group | Experimental | undergo ALND Receives: Procedure: ALND |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-surgery pathology concordance rate
post-surgery pathology concordance rate:investigate if the false negative rates in SLNB and ALND groups are consistent with post-surgery pathological results.
Measured: up to 3 weeks
Secondary outcomes (4)
Axillary drainage
daily quantity of drainage for patients
Measured: up to 3 weeks
Upper limb lymphatic drainage
Upper limb lymphatic drainage:investigate the changes in aim circumference 10 cm above and below the elbow two weeks, six months, 12 months after surgery, among SLNB, pALND and ALND groups.
Measured: up to 5 years
Axillary recurrence rate 3-5 years after surgery
Axillary recurrence rate 3-5 years after surgery:the time between the start of treatment and the first diagnosis of axillary recurrene.
Measured: up to 5 years
Upper limb lymphoedema
Clinical judgment is mainly by asking the patient's subjective feelings or physical examination and performing a multi-segment ratio for measurement. It is generally determined that the peripheral diameter of the upper limb on the affected side is longer than the circumference of the contralateral upper limb< 3 cm is mild edema, 3 to 5 cm is moderate edema, and the > 5 cm is severe edema.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Nov 2021
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2028 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianyi Li, Shengjing Hospital
- Investigators
- Jianyi Jianyi, Master, Principal investigator, Cancer Hospital of China Medical University, Liaoning Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241119
- Sponsor's protocol ID
- Shengjing-LJY06
- Status last verified
- Feb 2022
- First submitted
- 21 Dec 2021
- Last updated
- 15 Feb 2022
- 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 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise Treatment of Axillary Lymph Nodes After Neoadjuvant Chemotherapy Guided by Long-term Nanocarbon Tracing: a Clinical Cohort Study
- ClinicalTrials.gov ID
- NCT05241119
- Acronym / sponsor ID
- Shengjing-LJY06
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, neoadjuvant chemotherapy, lymph nodes, nanocarbon
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 15 Feb 2022 (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.
For patients with early breast cancer with negative axillary lymph nodes, sentinel lymph node biopsy (SLNB) can largely avoid complications such as upper limb lymphoedema caused by axillary lymph node dissection (ALND). Locally advanced breast cancer requires neoadjuvant chemotherapy (NAC), based on the breast cancer treatment guidelines. In addition to shrinking the primary breast lesion, NAC can reduce the stage for axillary positive lymph nodes. Therefore, in recent years clinicians have been considering SLNB for patients whose axillary lymph nodes have turned negative after NAC. After verification by the clinical trials, the current NCCN guidelines recommend that patients with T1-3N0-1 undergo SLNB after NAC, however, the false negative rate (FNR) of conventional SLNB after NAC is as high as 14%, which potentially leads to underestimation of the risk for recurrence and metastasis, insufficient adjuvant therapy, eventually affects long-term survival. Thus, how to accurately assess and treat axillary lymph nodes after NAC remains an urgent clinical question to be answered.
In recent years, a method using a metal clip to label positive lymph node before NAC has emerged in order to reduce the FNR of SLNB after NAC. Its principle is to trace the metastasized lymph node, so that the lymph node can be accurately found in the surgery, even if the lymph node is not blue-stained at the time. Apparently, this method is more suitable for small number of nodes, and inappropriate for more than two metastasized nodes.
The diameter of manocarbon particles (150nm) is between that of lymphatic capillaries (120-500nm) and capillaries (20-50 nm). With the unique macrophage phagocytosis, nanocarbon particles can remain in the lymphatic system for a long time. Using nanocarbon to label positive lymph nodes before NAC, our pilot study explored the regression of axillary lymph nodes after NAC. We found that, except for a small number of drug-resistant patients, the regression of positive lymph nodes after NAC followed a pattern of from the superior to the inferior, and from the medial to the lateral. We also found that, the worse the efficacy of NAC, the fewer black-stained nodes after NAC, suggesting long-term tracing of positive axillary lymph nodes by nanocarbon particles can guide precise treatment of axillary lymph nodes after NAC. These findings are integrated with our previous research project which investigated the spatial distribution of positive axillary lymph nodes with the intercostals brachial nerve (ICBN) as the boundary. It is proposed that low lymph node dissection below ICBN (pALND) may be a safe and efficient method reducing lymphoedema in patients with negative nodes after NAC. Prone position CT scan combined with clinical palpation of axillary lymph nodes can comprehensively evaluate axillary conditions in patients with breast cancer before surgery, and determine node metastasis accurately, and make correct clinical plans.
Detailed description
A total of 100 patients who are first diagnosed with breast cancer (stage N2 or N3) at the Liaoning Oncology Hospital will be recruited. Inclusive criteria: 1) Invasive breast cancer confirmed by biopsy and histology; 2) based on prone CT scan and Doppler ultrasound, axillary stage cN2-3; 3) agree and meet the requirements for NAC; 4) meet surgical requirements and agree to undergo surgery after NAC; 5) the regime of NAC follows the NCCN recommendations. Exclusive criteria: previous history of breast cancer or other malignant tumors. Period of investigation: 2 years.
After informed consent is obtained, under ultrasound guidance, the metastatic lymph node with the largest diameter (> 1 cm) is selected and injected under the cortex with 0.3 ml of nanocarbon. If the cortex and medulla are difficult to distinguish, inject on the surface of the node. Patients with efficacy for NAC should complete the scheduled cycles of NAC. Alteration of NAC regime is allowed for patients whose initial NAC is inefficacious, as guided by the physicians.
Surgery is performed within four weeks after completion of the last cycle of NAC. Axillary lymph nodes are assessed using CT scan. For patients with neoadjuvant efficacy of CR and PR, axillary surgery is performed under fluorescent tracing. SLNB is performed for patients with extensive black staining nodes. Standard ALND is performed if SLN is positive. For patients with less than three black-stained nodes, pALND will be performed rather than SLNB. If axilary lynph nodes under the ICBN are proved positive by frozen histology, ALND is then performed. For those with neoadjuvant efficacy of SD or PD, pALND will be performed if there are extensive black-stained nodes. Standard ALND will be performed if lymph nodes are positive as assessed by intraoperative frozen histology. ALND will be performed if the number of black-stained nodes is less than 3.
All the clinical information and imaging data will be securely preserved, including surgical procedure, black-stained and metastasized lymph nodes. Short-term observatory measures include axillary drainage (quantity, extubation time) and upper limb lymphatic drainage (changes in arm circumference 10cm above and below the elbow pre and post surgery. Long-term observatory measures include axillary recurrence rate and lymphoedema 3-5 years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SLNB Group | Experimental | Procedure: SLNBundergo fluorescence SLNB |
| pALND Group | Experimental | Procedure: pALNDundergo low axillary lymph node dissection with ICBN as the boundary |
| ALND Group | Experimental | Procedure: ALNDundergo ALND |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- invasive breast cancer confirmed by biopsy and histology;
- based on prone CT scan and Doppler ultrasound, axillary stage cN2-3;
- agree and meet the requirements for NAC;
- meet surgical requirements and agree to undergo surgery after NAC;
- the regime of NAC follows the NCCN recommendations.
Key exclusion criteria (1 listed)
- previous history of breast cancer or other malignant tumors.
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 |
|---|---|---|
| SLNBundergo fluorescence SLNB. | Procedure or surgery | SLNB Group |
| pALNDundergo low axillary lymph node dissection with ICBN as the boundary | Procedure or surgery | pALND Group |
| ALNDundergo ALND | Procedure or surgery | ALND Group |
Primary outcome
post-surgery pathology concordance rate
Time frame: up to 3 weeks
post-surgery pathology concordance rate:investigate if the false negative rates in SLNB and ALND groups are consistent with post-surgery pathological results.
4 secondary outcomes
Axillary drainage
Time frame: up to 3 weeks
Upper limb lymphatic drainage
Time frame: up to 5 years
Axillary recurrence rate 3-5 years after surgery
Time frame: up to 5 years
Upper limb lymphoedema
Time frame: up to 5 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 15 Feb 2022.
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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.
Jianyi Jianyi, Master principal investigator
Cancer Hospital of China Medical University, Liaoning Cancer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLNB, pALND and ALND in people with Breast Cancer, run by Shengjing Hospital at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Jianyi Li, Master (8618940257177, sjbreast@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-surgery pathology concordance rate (time frame: up to 3 weeks). 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 15 Feb 2022.