Breast CancerNCT03355261
Positive Node Traced Before Neoadjuvant Chemotherapy (NAC)
A study testing complete remission (CR) group, partial remission (PR) group and stable disease (SD) group in people with Breast Cancer, run by Shengjing Hospital at 3 sites in China.
Trial summary
To investigate this regression model by injecting and tracing carbon nanoparticles (CNs) into the fusion node prior to NAC in patients with breast cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- complete remission (CR) group, partial remission (PR) group and stable disease (SD) group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jul 2014to 1 Jul 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- invasive ductal carcinoma diagnosed by biopsy;
- clinically positive node diagnosed by contrast enhance computer tomography (CECT), the number of strengthened nodes at Level I ≥ 1 with the longest diameter of the strengthened node ≥ 2cm;
- NAC regimen followed the NCCN guideline;
- no prior history of breast cancer or other malignancies.
Who cannot join
- the cycle number of neo-adjuvant chemotherapy is equal to or less than 2
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Second Hospital of Jilin University
Changchun, Jilin
the First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
About this study
Official title: Long-term Tracing for Axillary Lymph Nodes Dissection in the Patients With Fusion Lymph Node Before Neo-adjuvant Chemotherapy
To investigate this regression model by injecting and tracing carbon nanoparticles (CNs) into the fusion node prior to NAC in patients with breast cancer.
Read the detailed description
Guided by ultrasound, 0.3 mL of CNs suspension was injected in a fusion node prior to NAC in 110 patients with local advanced breast cancer. Patients underwent breast surgery and total axillary lymph node dissection following 2-6 cycles of NAC. The distribution by intercostobrachial nerves (ICBN) of positive nodes, black-stained nodes and lymphovascular invasion was investigated by response to NAC.
- Conditions
- Breast Cancer
- Being tested
- complete remission (CR) group, partial remission (PR) group, stable disease (SD) group, progressive disease (PD) group
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete remission (CR) groupProcedure or surgery
According to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC).
partial remission (PR) groupProcedure or surgery
According to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC).
stable disease (SD) groupProcedure or surgery
According to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC).
progressive disease (PD) groupProcedure or surgery
According to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC).
| Study group | Role | What they receive |
|---|---|---|
| complete remission (CR) group | Experimental | According to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC). Receives: Procedure: complete remission (CR) group |
| partial remission (PR) group | Experimental | According to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC). Receives: Procedure: partial remission (PR) group |
| stable disease (SD) group | Experimental | According to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC). Receives: Procedure: stable disease (SD) group |
| progressive disease (PD) group | Experimental | According to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC). Receives: Procedure: progressive disease (PD) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on pectoralis minor location
After neoadjuvant chemotherapy, whether positive nodes remission (transform to negative), from Level III to Level II, and from Level II to Level I. This means that if the nodes at Level I are negative, the nodes at Level II or Level III will be negative; if the nodes at Level II are negative, the nodes at Level III will be negative; if the nodes at Level III are positive, the nodes at Level I and Level II will be positive.
Measured: During the surgery
Secondary outcomes (2)
The spatial distribution of black-stained in axillary after neoadjuvant chemotherapy based on pectoralis minor location
If the chemotherapy is sensitive, the number of black-stained nodes will increase from Level I, Level II, to Level III. If the chemotherapy is resistance, the number of black-stained nodes will remain the original number or a little increasing locally.
Measured: During the surgery
The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on intercostobrachiales nerves (ICBN) location
After neoadjuvant chemotherapy, whether positive nodes remission (transform to negative), from above ICBN to below ICBN. This means that if the nodes below ICBN are negative, the nodes above ICBN will be negative; if the nodes above ICBN are positive, the nodes below ICBN will be positive.
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Jul 2014
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianyi Li, Shengjing Hospital
- Investigators
- Jianyi Li, Master, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355261
- Sponsor's protocol ID
- ShengjingH01
- Status last verified
- Feb 2020
- First submitted
- 14 Nov 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li J, Jia S, Wang Y, Zhang Y, Kong L, Cao Y, Liu Y, Zhang Y, Chen B. Long-term tracing and staining of carbon nanoparticles for axillary lymph nodes in patients with locally advanced breast cancer treated with neoadjuvant chemotherapy. Asian J Surg. 2022 Jan;45(1):89-96. doi: 10.1016/j.asjsur.2021.03.020. Epub 2021 Apr 27.
PubMed 33926797
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Tracing for Axillary Lymph Nodes Dissection in the Patients With Fusion Lymph Node Before Neo-adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03355261
- Acronym / sponsor ID
- ShengjingH01
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 28 Nov 2017 (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.
To investigate this regression model by injecting and tracing carbon nanoparticles (CNs) into the fusion node prior to NAC in patients with breast cancer.
Detailed description
Guided by ultrasound, 0.3 mL of CNs suspension was injected in a fusion node prior to NAC in 110 patients with local advanced breast cancer. Patients underwent breast surgery and total axillary lymph node dissection following 2-6 cycles of NAC. The distribution by intercostobrachial nerves (ICBN) of positive nodes, black-stained nodes and lymphovascular invasion was investigated by response to NAC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| complete remission (CR) group | Experimental | Procedure: complete remission (CR) groupAccording to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC). |
| partial remission (PR) group | Experimental | Procedure: partial remission (PR) groupAccording to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC). |
| stable disease (SD) group | Experimental | Procedure: stable disease (SD) groupAccording to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC). |
| progressive disease (PD) group | Experimental | Procedure: progressive disease (PD) groupAccording to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- invasive ductal carcinoma diagnosed by biopsy;
- clinically positive node diagnosed by contrast enhance computer tomography (CECT), the number of strengthened nodes at Level I ≥ 1 with the longest diameter of the strengthened node ≥ 2cm;
- NAC regimen followed the NCCN guideline;
- no prior history of breast cancer or other malignancies.
Key exclusion criteria (1 listed)
- the cycle number of neo-adjuvant chemotherapy is equal to or less than 2
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 |
|---|---|---|
| complete remission (CR) groupAccording to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC). | Procedure or surgery | complete remission (CR) group |
| partial remission (PR) groupAccording to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC). | Procedure or surgery | partial remission (PR) group |
| stable disease (SD) groupAccording to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC). | Procedure or surgery | stable disease (SD) group |
| progressive disease (PD) groupAccording to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC). | Procedure or surgery | progressive disease (PD) group |
Primary outcome
The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on pectoralis minor location
Time frame: During the surgery
After neoadjuvant chemotherapy, whether positive nodes remission (transform to negative), from Level III to Level II, and from Level II to Level I. This means that if the nodes at Level I are negative, the nodes at Level II or Level III will be negative; if the nodes at Level II are negative, the nodes at Level III will be negative; if the nodes at Level III are positive, the nodes at Level I and Level II will be positive.
2 secondary outcomes
The spatial distribution of black-stained in axillary after neoadjuvant chemotherapy based on pectoralis minor location
Time frame: During the surgery
The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on intercostobrachiales nerves (ICBN) location
Time frame: During the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 33926797Li J, Jia S, Wang Y, Zhang Y, Kong L, Cao Y, Liu Y, Zhang Y, Chen B. Long-term tracing and staining of carbon nanoparticles for axillary lymph nodes in patients with locally advanced breast cancer treated with neoadjuvant chemotherapy. Asian J Surg. 2022 Jan;45(1):89-96. doi: 10.1016/j.asjsur.2021.03.020. Epub 2021 Apr 27.
- Individual participant dataSharing planned: Undecided
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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.
Jianyi Li, Master principal investigator
Shengjing Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing complete remission (CR) group, partial remission (PR) group and stable disease (SD) group in people with Breast Cancer, run by Shengjing Hospital at 3 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 4 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: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on pectoralis minor location (time frame: During the surgery). 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 NCT03355261, 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 20 Feb 2020.