Sentinel Lymph Node BiopsyNCT06518135
Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer
An observational study of Sentinel Lymph Node Biopsy, run by Henan Cancer Hospital at 1 site in China.
Trial summary
SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long-term tumor safety data is still insufficient. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sentinel Lymph Node Biopsy
- What is being tested?
- SLNB group
- How many people
- 508 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2024to 31 Mar 2028
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients with positive initial cT1-3N1 axillary lymph nodes
Who may be able to join
- Patients With ECOG Score 0-1 Points
- Patients With Breast Cancer Stage cT1-3N1M0 (According to AJCC Version 7) Pathological Diagnosis of Ipsilateral Axillary Lymph Node Metastasis in Patients With Invasive Breast Cancer
- Patients With Abnormal Axillary Lymph Nodes ≤ 3 Detected by Imaging Examination
- Patients With Effective Neoadjuvant Therapy (CR+PR)
- Patients With Clinical Axillary Negative ycN0 After Neoadjuvant Therapy
- Patients Without Prior History of Ipsilateral Axillary Surgery and Radiation Therapy
Show all 11Show fewer
- Patients Without Previous History of Ipsilateral Breast Cancer (Including Carcinoma in Situ)
- Patients Without Obvious Contraindications for Surgery or Radiation Therapy
- No Other History of Malignant Tumors Within 5 Years From Enrollment in the Study
- Patients Who Participate in Other Clinical Trials at the Same Time and Are Judged by the Researchers Not to Affect the Study Protocol Can be Enrolled Normally
- The patient voluntarily joined this study and signed an informed consent form.
Who cannot join
- Stage IV (metastatic) breast cancer；
- Simultaneous double breast cancer；
- Baseline cT4;
- Baseline cN2-3
- gestation
- There are contraindications for SLNB;
- Suffering from serious comorbidities or other comorbidities that may interfere with the planned treatment, or any other circumstances in which the researcher deems the patient unsuitable to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Minhao Lv contact
China1 site, 1 recruiting
- Recruiting
Henan cacer hospital
Henan, Henan, 450008
Liu Zhen, 13838308034
About this study
Official title: Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer: a Prospective, Multicenter, Single Arm, Real World Study
SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long-term tumor safety data is still insufficient. Therefore, it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real world.This study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies.
Read the detailed description
SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long-term tumor safety data is still insufficient. Therefore, it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real world.This study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies. The main endpoint of the study was axillary recurrence free survival. The secondary study endpoints were regional lymph node recurrence free survival, disease-free survival, overall survival, incidence of postoperative upper limb lymphedema, and patient quality of life.
- Conditions
- Sentinel Lymph Node Biopsy
- Being tested
- SLNB group
- Keywords
- Axillary sentinel lymph node biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLNB groupOther
Also called experimental group
After the completion of neoadjuvant therapy, axillary SLNB should be performed first before breast surgery; If the frozen pathology SLNs are negative, ALND will no longer be performed; If frozen pathological SLNs are positive, ALND should be performed directly; If frozen pathology is false negative.
| Study group | Role | What they receive |
|---|---|---|
| SLNB group | Standard sentinel lymph node biopsy group, if frozen pathology SLNs are negative, no ALND will be performed; If frozen pathological SLNs are positive, ALND should be performed directly; If the frozen pathology is false negative, it is recommended to complete ALND within 12 weeks after SLNB surgery. Receives: Other: SLNB group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axillary recurrence-free survival
The time from surgery to axillary recurrence or last follow-up
Measured: 5th year after surgery
Secondary outcomes (5)
regional lymph node recurrence-free survival
The time from surgery to the occurrence of regional lymph node recurrence, metastasis, or last follow-up
Measured: 5th year after surgery
Disease-free survival
The time from surgery to the occurrence of recurrence, metastasis, or last follow-up
Measured: 5th year after surgery
Overall survival
The time from surgery to patient death or last follow-up
Measured: 5th year after surgery
The incidence of postoperative upper limb lymphedema
By using the circumference method, the styloid process of the ulna is taken as the starting point, with an interval of 10cm and measured up to 40cm. The circumference is measured, and the volume of the affected limb is ≥ 10% or>200ml.
Measured: 5th year after surgery
EORTC-QLQ-C30 V3 rating
The EORTC-QLQ-C30 V3 is the core scale of the quality of life measurement system developed by the European Organization for Research and Treatment of Cancer (EORTC) for cancer patients.
The scale consists of 30 items, including 5 functional scales (physical function, role function, cognitive function, emotional function, social function), 3 symptom scales (fatigue, pain, malignant vomiting), 6 individual measurement items (swallowing difficulties, loss of appetite, sleep disorders, constipation, diarrhea, economic difficulties), and 1 patient self-assessment item (overall health status).
The original scores for each item need to be converted into standardized scores ranging from 0 to 100 using a linear formula. The higher the score for each functional dimension, the better the functional status; The higher the score of the symptom scale and individual items, the more obvious the symptoms and the poorer the quality of life.
Measured: 5th year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start30 Apr 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sentinel Lymph Node BiopsyStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zhenzhen Liu, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518135
- Sponsor's protocol ID
- 2024-157
- Status last verified
- May 2024
- First submitted
- 18 Jul 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer: a Prospective, Multicenter, Single Arm, Real World Study
- ClinicalTrials.gov ID
- NCT06518135
- Acronym / sponsor ID
- 2024-157
- Conditions
- Sentinel Lymph Node Biopsy
- Keywords
- Axillary sentinel lymph node biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 508 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Jul 2024 (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.
SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long-term tumor safety data is still insufficient. Therefore, it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real world.This study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies.
Detailed description
SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long-term tumor safety data is still insufficient. Therefore, it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real world.This study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies. The main endpoint of the study was axillary recurrence free survival. The secondary study endpoints were regional lymph node recurrence free survival, disease-free survival, overall survival, incidence of postoperative upper limb lymphedema, and patient quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLNB group | – | Other: SLNB groupStandard sentinel lymph node biopsy group, if frozen pathology SLNs are negative, no ALND will be performed; If frozen pathological SLNs are positive, ALND should be performed directly; If the frozen pathology is false negative, it is recommended to complete ALND within 12 weeks after SLNB surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients with positive initial cT1-3N1 axillary lymph nodes
Key inclusion criteria (11 listed)
- Patients With ECOG Score 0-1 Points
- Patients With Breast Cancer Stage cT1-3N1M0 (According to AJCC Version 7) Pathological Diagnosis of Ipsilateral Axillary Lymph Node Metastasis in Patients With Invasive Breast Cancer
- Patients With Abnormal Axillary Lymph Nodes ≤ 3 Detected by Imaging Examination
- Patients With Effective Neoadjuvant Therapy (CR+PR)
- Patients With Clinical Axillary Negative ycN0 After Neoadjuvant Therapy
Key exclusion criteria (7 listed)
- Stage IV (metastatic) breast cancer；
- Simultaneous double breast cancer；
- Baseline cT4;
- Baseline cN2-3
- gestation
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 |
|---|---|---|
| SLNB groupAlso: experimental groupAfter the completion of neoadjuvant therapy, axillary SLNB should be performed first before breast surgery; If the frozen pathology SLNs are negative, ALND will no longer be performed; If frozen pathological SLNs are positive, ALND should be performed directly; If frozen pathology is false negative. | Other | SLNB group |
Primary outcome
Axillary recurrence-free survival
Time frame: 5th year after surgery
The time from surgery to axillary recurrence or last follow-up
5 secondary outcomes
regional lymph node recurrence-free survival
Time frame: 5th year after surgery
Disease-free survival
Time frame: 5th year after surgery
Overall survival
Time frame: 5th year after surgery
The incidence of postoperative upper limb lymphedema
Time frame: 5th year after surgery
EORTC-QLQ-C30 V3 rating
Time frame: 5th year after surgery
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 17 Dec 2024.
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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.
Minhao Lv contact
Zhenzhen Liu principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sentinel Lymph Node Biopsy, run by Henan Cancer Hospital 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 11 inclusion and 7 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 17 Dec 2024. 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?
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 Zhenzhen Liu (0371-65587005, liuzhenzhen73@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axillary recurrence-free survival (time frame: 5th year after surgery). 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 17 Dec 2024.