Condition category
Cancer
Date applied
23/10/2019
Date assigned
29/10/2019
Last edited
28/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Axillary lymph node evaluation is one of the important indicators for clinical pathological staging of breast cancer. However, for patients receiving neoadjuvant chemotherapy, the timing of sentinel lymph node biopsy is still controversial. This study will investigate the feasibility and safety of sentinel lymph node biopsy in Chinese patients with cN1 breast cancer who undergo routine radical surgery after neoadjuvant chemotherapy under current medical conditions in China

Who can participate? 
Eligible patients with cN1 breast cancer at 18-70 years of age of either sex

What does the study involve?
All enrolled patients will undergo neoadjuvant chemotherapy, radical mastectomy and intraoperative sentinel lymph node biopsy. All enrolled patients will receive this treatment and undergo lymph node diagnosis and evaluation after surgery

What are the possible benefits and risks of participating?
Eligible patients included in this study may not get direct benefits, but they will get more medical attention from investigators. Lymph node tracers methylene blue and carbon nanoparticles can cause local skin necrosis, but this risk can be avoided by rigorous intraoperative operation

Where is the study run from? 
1. The First Hospital of China Medical University (lead center)
2. Shengjing Hospital of China Medical University
3. Liaoning Cancer Hospital & Institute
4. Affiliated Zhongshan Hospital of Dalian University
5. The Second Hospital of Dalian Medical University
6. The Fourth Affiliated Hospital of China Medical University, China.

When is the study starting and how long is it expected to run for?
The anticipated start date of this study is December 2019 and the anticipated end date of this study is February 2022. The duration of the trial is approximate 2 years.

Who is funding the study?
This study will be funded by Liaoning Province Distinguished Professor Fund (LWF [2017] No.3)

Who is the main contact?
Lei Zhang, Project secretary
zhl656144@163.com

Trial website

Contact information

Type

Public

Primary contact

Prof Bo Chen

ORCID ID

http://orcid.org/0000-0001-6372-8806

Contact details

No.155 Nanjing North Street
Heping District
Shenyang
Liaoning Province
Shenyang
110001
China
+861 5904025211
chbyxl@163.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1.0

Study information

Scientific title

Feasibility of sentinel lymph node biopsy using dye alone method in Chinese patients with cN1 breast cancer after neoadjuvant chemotherapy evaluated by clinical physical examination and three-dimensional ultrasound: a prospective, multicenter, diagnostic trial

Acronym

Study hypothesis

For patients receiving neoadjuvant chemotherapy, the timing of sentinel lymph node biopsy is still controversial. Although some results have been achieved in this respect, the results also have some limitations. Based on this, this study will investigate the feasibility and safety of sentinel lymph node biopsy in Chinese patients with cN1 breast cancer who undergo routine radical axillary lymph node dissection after neoadjuvant chemotherapy under current medical conditions in China

Ethics approval

Approved 06/08/2019, Medical Ethics Committee, First Hospital of China Medical University (No.155 Nanjing North Street, Heping District, Shenyang, Liaoning Province, China; yykyk@vip.163.com; +86-024-83282837), ref: KLS[2019]2019-193-2

Study design

Prospective multicenter diagnostic trial

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Breast cancer

Intervention

The enrolled patients will receive neoadjuvant chemotherapy. After neoadjuvant chemotherapy and before radical axillary lymph node dissection, sentinel lymph node tracer will be injected. Before routine axillary lymph node dissection, sentinel lymph node biopsy will be performed. The dissected sentinel lymph nodes and other axillary lymph nodes will be marked separately for routine pathological examination.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

False negative rate of sentinel lymph node biopsy at postoperative day one, according to pathological results and referencing to gold standard, false negative rate of sentinel lymph nodes = (number of patients having false negative sentinel lymph nodes/number of patients having gold standard results) ×100%

Secondary outcome measures

1. At postoperative day one, the relationship between each influential factor (neoadjuvant efficacy, tumor location, surgical procedure, number of sentinel lymph nodes detected, molecular subtypes of breast cancer (luminal A, luminal B, HER2-positive, triple-negative)) and the results of sentinel lymph node biopsy after neoadjuvant chemotherapy
2. Adverse events during the trial

Overall trial start date

01/03/2019

Overall trial end date

20/02/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women, age at 18-70 years
2. Primary invasive breast adenocarcinoma confirmed by physical examination, breast color Doppler ultrasound, mammography, MRI evaluation, and hollow needle histological examination. Before treatment, all patients have cN1 lymph nodes, i.e., subaxillary enlarged lymph nodes palpable by clinical examination and/or suspected positive enlarged lymph nodes revealed by related examinations, which are not considered as metastatic lymph nodes;
3. Not previously received treatment for breast cancer, agree to participate in the study, and have good compliance
4. The Eastern Cooperative Oncology Group (ECOG) performance status grade 0-2
5. Before treatment, the results of hematological and biochemical examinations should meet the following conditions: white blood cells ≥ 4.0 x 109/L, absolute neutrophil count ≥ 1.5 x 109/L,  platelet count ≥ 100 x 109/L, hemoglobin ≥ 90 g/L, glutathione transaminase, alanine transaminase ≤ 1.5 x upper limit of normal, creatinine ≤ 1.5 x upper limit of normal, total bilirubin ≤ 1.5 x upper limit of normal
6. No serious heart, liver and kidney diseases

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

500

Participant exclusion criteria

1. No provision of written informed consent
2. Lactating or pregnant women
3. Confirmed distant metastasis of breast cancer
4. Sensory or motor neuropathy, or those diagnosed with psychiatric disorder
5. Confirmed cardiovascular diseases, serious concomitant diseases or active infections including known human immunodeficiency virus infection
6. History of other cancers
7. Allergic to drugs and excipients involved in tracers and neoadjuvant chemotherapy

Recruitment start date

30/12/2019

Recruitment end date

30/12/2021

Locations

Countries of recruitment

China

Trial participating centre

The First Hospital of China Medical University
No.155 Nanjing North Street Heping District Shenyang Liaoning Province
Shenyang
110001
China

Trial participating centre

Liaoning Cancer Hospital & Institute
No. 44 Xiaoheyan Road Dadong District Shenyang Liaoning Province
Shenyang
110042
China

Trial participating centre

Affiliated Zhongshan Hospital of Dalian University
No. 6 Jiefang Street Zhongshan District Dalian Liaoning Province
Dalian
116004
China

Trial participating centre

The Second Hospital of Dalian Medical University
No. 467 Zhongshan Road Shahekou District Dalian Liaoning Province
Dalian
116023
China

Trial participating centre

The Fourth Affiliated Hospital of China Medical University
No. 4 Chongshan Road Huanggu District Shenyang Liaoning Province
Shenyang
110033
China

Sponsor information

Organisation

The First Hospital of China Medical University

Sponsor details

No.155 Nanjing North Street
Heping District
Shenyang
Liaoning Province
Shenyang
110001
China
+861 5904025211
chbyxl@163.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Liaoning Province Distinguished Professor Fund of China (LWF [2017] No.3)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

30/06/2023

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/10/2019: Trial’s existence confirmed by Medical Ethics Committee, First Hospital of China Medical University