Breast CancerNCT03857932
Establishment and Clinical Application of Precise SLNB System in Breast Cancer: a Randomized, Multicenter, Controlled Study
A study testing Participants receive SLNB as well as non SLNs resection in people with Breast Cancer, run by Shandong University at 1 site in China.
Trial summary
The investigatorsconduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. The investigators aimed to summarize the law of lymphatic drainage of breast, and to conduct the accurate surgical treatment of breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Participants receive SLNB as well as non SLNs resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2025
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy
- abnormal para-sentinel lymph node was found by ultrasound examination
- ultrasound-guided fine needle aspiration cytology of these nodes were performed
- the result of fine needle aspiration cytology was negative (no tumour cell was found)
- participants planed to perform SLNB
Who cannot join
- pathological diagnosed ductal carcinoma in situ by excisional biopsy
- the result of fine needle aspiration cytology was positive
- participants has received neo-adjuvant system therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qifeng Yang
Jinan, Shandong, 250012
Qifeng Yang, +8618560085168
Xiaoyan Li, +8618560080551, wdjlc108822@163.com
About this study
Official title: Clinical Study on Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer
The investigatorsconduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. The investigators aimed to summarize the law of lymphatic drainage of breast, and to conduct the accurate surgical treatment of breast cancer.
Read the detailed description
AIM:Sentinel lymph node biopsy (SLNB) is the standard technique for patients with early stage breast cancer. The investigators conduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. And The investigators identify the true sentinel lymph nodes(SLNs) followed by lymphatic ducts during operation. The investigators aimed to identify the non-sentinel lymph node, and to investigate the relationship between upper extremity lymphatic drainage. The SLNB procedure could avoid unnecessary lymph node resection and reduce treatment-related sequela.
Arm1：
- Participants received preoperative computed tomographic lymphography
- Participants received sentinel lymph node biopsy（SLNB）
- Participants received stained non-sentinel lymph node resection during SLNB
- Participants received axillary reverse mapping dissection Arm2： Participants receive sentinel lymph node biopsy
- Conditions
- Breast Cancer
- Being tested
- Participants receive SLNB as well as non SLNs resection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants receive SLNB as well as non SLNs resectionProcedure or surgery
Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection
| Study group | Role | What they receive |
|---|---|---|
| SLNB and non-slns resection | Experimental | 1. Participants only receive SLNB
2. preoperative CT lymphography
3. SLNB with stained non-SLN resection
4. SLNB with ARM dissection Receives: Procedure: Participants receive SLNB as well as non SLNs resection |
| SLNB group | Experimental | Participants only receive SLNB Receives: Procedure: Participants receive SLNB as well as non SLNs resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years.
Measured: Up to 10 years
Secondary outcomes (1)
Overall survival
Time from randomization to death from any cause, assessed up to 10 years.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Jan 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qifeng Yang, Shandong University
- Investigators
- Qifeng Yang, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857932
- Sponsor's protocol ID
- HECT004
- Status last verified
- Aug 2021
- First submitted
- 26 Feb 2019
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT03857932
- Acronym / sponsor ID
- HECT004
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Feb 2019 (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 investigatorsconduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. The investigators aimed to summarize the law of lymphatic drainage of breast, and to conduct the accurate surgical treatment of breast cancer.
Detailed description
AIM:Sentinel lymph node biopsy (SLNB) is the standard technique for patients with early stage breast cancer. The investigators conduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. And The investigators identify the true sentinel lymph nodes(SLNs) followed by lymphatic ducts during operation. The investigators aimed to identify the non-sentinel lymph node, and to investigate the relationship between upper extremity lymphatic drainage. The SLNB procedure could avoid unnecessary lymph node resection and reduce treatment-related sequela.
Arm1：
- Participants received preoperative computed tomographic lymphography
- Participants received sentinel lymph node biopsy（SLNB）
- Participants received stained non-sentinel lymph node resection during SLNB
- Participants received axillary reverse mapping dissection Arm2： Participants receive sentinel lymph node biopsy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLNB and non-slns resection | Experimental | Procedure: Participants receive SLNB as well as non SLNs resection1. Participants only receive SLNB 2. preoperative CT lymphography 3. SLNB with stained non-SLN resection 4. SLNB with ARM dissection |
| SLNB group | Experimental | Procedure: Participants receive SLNB as well as non SLNs resectionParticipants only receive SLNB |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy
- abnormal para-sentinel lymph node was found by ultrasound examination
- ultrasound-guided fine needle aspiration cytology of these nodes were performed
- the result of fine needle aspiration cytology was negative (no tumour cell was found)
- participants planed to perform SLNB
Key exclusion criteria (3 listed)
- pathological diagnosed ductal carcinoma in situ by excisional biopsy
- the result of fine needle aspiration cytology was positive
- participants has received neo-adjuvant system therapy
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 |
|---|---|---|
| Participants receive SLNB as well as non SLNs resectionParticipants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection | Procedure or surgery | SLNB and non-slns resection, SLNB group |
Primary outcome
Disease free survival
Time frame: Up to 10 years
Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years.
1 secondary outcome
Overall survival
Time frame: Up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
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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.
Qifeng Yang principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participants receive SLNB as well as non SLNs resection in people with Breast Cancer, run by Shandong 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 31 Aug 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 Qifeng Yang (+8618560085168, qifengy_sdu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: Up to 10 years). 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 31 Aug 2021.