Positive Node Traced Before Neoadjuvant Chemotherapy (NAC)
Long-term Tracing for Axillary Lymph Nodes Dissection in the Patients With Fusion Lymph Node Before Neo-adjuvant Chemotherapy
1 other identifier
interventional
110
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jul 2014
Typical duration for not_applicable breast-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 14, 2017
CompletedFirst Posted
Study publicly available on registry
November 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedFebruary 20, 2020
February 1, 2020
4 years
November 14, 2017
February 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
During the surgery
Secondary Outcomes (2)
The spatial distribution of black-stained in axillary after neoadjuvant chemotherapy based on pectoralis minor location
During the surgery
The spatial distribution of positive nodes in axillary after neoadjuvant chemotherapy based on intercostobrachiales nerves (ICBN) location
During the surgery
Study Arms (4)
complete remission (CR) group
EXPERIMENTALAccording 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
EXPERIMENTALAccording 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
EXPERIMENTALAccording 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
EXPERIMENTALAccording to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC).
Interventions
According to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC).
According to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC).
According to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC).
According to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- the cycle number of neo-adjuvant chemotherapy is equal to or less than 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
The Second Hospital of Jilin University
Changchun, Jilin, China
the First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Related Publications (1)
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.
PMID: 33926797DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianyi Li, Master
Shengjing Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 14, 2017
First Posted
November 28, 2017
Study Start
July 1, 2014
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
February 20, 2020
Record last verified: 2020-02