Breast CancerNCT04986306
The Validation of Sentinel Lymph Node Biopsy After Neo-adjuvant Chemotherapy in Breast Cancer Patients
An observational study of Breast Cancer and Sentinel Lymph Node Biopsy, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Neoadjuvant or primary systemic treatment is increasingly applied in the treatment of operable breast cancer. Down staging of the primary tumor is one of the important goals of neoadjuvant chemotherapy treatment (NCT), thereby permitting breast-conserving treatment without affecting the risk for a local relapse. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer, Sentinel Lymph Node Biopsy, Neoadjuvant Therapy
- What is being tested?
- SLNB + ALND
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 May 2021to Dec 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Groups will be formed of the breast cancer patients who meet the eligible criteria
Who may be able to join
- Age ≥ 20 years.
- Female
- Primary breast cancer, not metastasis from other cancer.
- Histological subtypes: invasive ductal carcinoma.
- Clinical stage: cT1-3, cN1, cM0.
- Clip localization over at least one axillary lymph node.
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- After neoadjuvant chemotherapy (NCT). The inclusion criteria and regimens of NCT are followed standard guildline of National Cheng Kung University Hospital.
- Complete response or partial response after NCT.
- Written inform consent.
Who cannot join
- Refuse to join the study.
- Unable to complete standard regimens of NCT.
- Metastasis in internal mammary nodes or other distant lymph nodes.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Validation of Sentinel Lymph Node Biopsy After Neo-adjuvant Chemotherapy in Breast Cancer Patients in National Cheng Kung University Hospital (NCKUH)
Neoadjuvant or primary systemic treatment is increasingly applied in the treatment of operable breast cancer. Down staging of the primary tumor is one of the important goals of neoadjuvant chemotherapy treatment (NCT), thereby permitting breast-conserving treatment without affecting the risk for a local relapse. Complete pathological response (pCR) rates after NCT vary across histological subtypes and can be more than 60% in HER2-positive disease with dual blockade therapy. Down staging of the axilla is also observed in patients initially presenting with metastatic lymph nodes. pCR rates in the axilla vary between 22% and 42% in reported series, again depending on tumor subtype. Omission of axillary lymph node dissection (ALND) can avoid the post-operative morbidity such as lymphedema in the short or long term follow-up.
Metastatic lymph node status is hard to be stated as a pCR in the axilla by using physical examination or imaging such as ultrasonography or tomography after complete NCT. Good response to the axilla lymph node causing the difficulty of tissue proof by using core needle biopsy, though the investigator knew that biopsy stands for the definite tool for the confirmation of the residual disease. One proposed method to decrease the false-negative rate (FNR) is clip placement in the positive node at initial diagnosis with confirmation of clipped node resection at surgery.
Read more
The correlation between the axillary lymph node identified on initial axillary ultrasound and the sentinel lymph nodes (SLNs) identified at surgery has not been fully evaluated. The concordance between percutaneous biopsy and the lymph node resected at the time of SLNB is not 100%. Sometimes, the initial node identified by ultrasound is not one of the SLNs. The impairment of the performance of SLNB might correlated to the alteration of lymphatic flow induced by tissue fibrosis or tumor deposits after NCT.
The investigator hypothesized that the clip placement at diagnosis of node-positive disease with removal of the clipped node during SLNB reduces the FNR of SLNB after NCT. Here, we evaluate how often the lymph node containing the clip placed at percutaneous biopsy before chemotherapy was found at surgery to be one of the SLNs, and how often it was found in the nodes retrieved at ALND. In addition, the investigator report the impact of identification of the clipped node within the SLNs on the FNR of SLNB.
Read the detailed description
Aim 1: Identify the pathological result of SLN and ALN
Hypothesis:
The lymph node containing the clip placed at percutaneous biopsy before chemotherapy was found at surgery to be one of the SLNs
Method:
This study is a prospective study. 30 patients who will undergo neoadjuvant chemotherapy were asked to participate in this study. Informed consent will be given. Clip will be placed over the positive lymph node by surgeon which was proven by fine-needle aspiration cytology. After completion of neoadjuvant chemotherapy, surgery of the breast and the axilla was executed in the same session. Different surgeons performed the procedure.
The SLNB will be performed by dual tracer (blue dye plus indocyanine green or radioisotope). After remove the SLNs and ALN, detection of the clipped node will be identified under mammography-guided. The clipped lymph node will be marked separately. All of the lymph node will be sent to pathologist for final examination.
Aim 2: Check the feasibility of SLNB after neoadjuvant CT
Hypothesis:
SLNB is feasible after neoadjuvant CT under certain circumstances.
Method:
The primary endpoints used for statistical analysis were the success rate for identifying and selectively removing the clipped node and the correlation of the response observed in the clipped node on pathology with the ALND specimen. The identification rate of the clipped node was analyzed in all patients who underwent surgical removal of the clipped node. Correlation between the pathologic response observed in the clipped node and in the ALND specimen was estimated using false-negative rates, sensitivity, specificity, positive predictive value, negative predictive value, and accuracy.
- Being tested
- SLNB + ALND
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLNB + ALNDProcedure or surgery
Patients who received neoadjuvant chemotherapy will undergo SLNB+ALND to evaluate the feasibility of SLNB
| Study group | Role | What they receive |
|---|---|---|
| clinical tumor stage 1-3 (cT1-3) and nodal stage 1 (cN1) breast cancer patients | Patients who will undergo neoadjuvant chemotherapy were asked to participate in this study. Informed consent will be given. Clip will be placed over the positive lymph node by surgeon which was proven by fine-needle aspiration cytology. After completion of neoadjuvant chemotherapy, surgery of the breast and the axilla was executed in the same session. Different surgeons performed the procedure. Receives: Procedure: SLNB + ALND |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of clipped lymph node in patients who received SLNB and ALND following neoadjuvant chemotherapy
compare the location of clipped lymph node in SLNB or ALND
Measured: immediately after the surgery
Secondary outcomes (1)
Correlation of the pathologic response observed in the clipped node and SLNB
estimate the accuracy of SLNB by using false-negative rates, sensitivity, specificity, positive predictive value, negative predictive value
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start20 May 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (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.
- More trials run by National Cheng-Kung University 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
- 30 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loh, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986306
- Sponsor's protocol ID
- NCKUH SLNB
- Status last verified
- Jun 2021
- First submitted
- 30 Jun 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validation of Sentinel Lymph Node Biopsy After Neo-adjuvant Chemotherapy in Breast Cancer Patients in National Cheng Kung University Hospital (NCKUH)
- ClinicalTrials.gov ID
- NCT04986306
- Acronym / sponsor ID
- NCKUH SLNB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Aug 2021 (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.
Neoadjuvant or primary systemic treatment is increasingly applied in the treatment of operable breast cancer. Down staging of the primary tumor is one of the important goals of neoadjuvant chemotherapy treatment (NCT), thereby permitting breast-conserving treatment without affecting the risk for a local relapse. Complete pathological response (pCR) rates after NCT vary across histological subtypes and can be more than 60% in HER2-positive disease with dual blockade therapy. Down staging of the axilla is also observed in patients initially presenting with metastatic lymph nodes. pCR rates in the axilla vary between 22% and 42% in reported series, again depending on tumor subtype. Omission of axillary lymph node dissection (ALND) can avoid the post-operative morbidity such as lymphedema in the short or long term follow-up.
Metastatic lymph node status is hard to be stated as a pCR in the axilla by using physical examination or imaging such as ultrasonography or tomography after complete NCT. Good response to the axilla lymph node causing the difficulty of tissue proof by using core needle biopsy, though the investigator knew that biopsy stands for the definite tool for the confirmation of the residual disease. One proposed method to decrease the false-negative rate (FNR) is clip placement in the positive node at initial diagnosis with confirmation of clipped node resection at surgery.
The correlation between the axillary lymph node identified on initial axillary ultrasound and the sentinel lymph nodes (SLNs) identified at surgery has not been fully evaluated. The concordance between percutaneous biopsy and the lymph node resected at the time of SLNB is not 100%. Sometimes, the initial node identified by ultrasound is not one of the SLNs. The impairment of the performance of SLNB might correlated to the alteration of lymphatic flow induced by tissue fibrosis or tumor deposits after NCT.
The investigator hypothesized that the clip placement at diagnosis of node-positive disease with removal of the clipped node during SLNB reduces the FNR of SLNB after NCT. Here, we evaluate how often the lymph node containing the clip placed at percutaneous biopsy before chemotherapy was found at surgery to be one of the SLNs, and how often it was found in the nodes retrieved at ALND. In addition, the investigator report the impact of identification of the clipped node within the SLNs on the FNR of SLNB.
Detailed description
Aim 1: Identify the pathological result of SLN and ALN
Hypothesis:
The lymph node containing the clip placed at percutaneous biopsy before chemotherapy was found at surgery to be one of the SLNs
Method:
This study is a prospective study. 30 patients who will undergo neoadjuvant chemotherapy were asked to participate in this study. Informed consent will be given. Clip will be placed over the positive lymph node by surgeon which was proven by fine-needle aspiration cytology. After completion of neoadjuvant chemotherapy, surgery of the breast and the axilla was executed in the same session. Different surgeons performed the procedure.
The SLNB will be performed by dual tracer (blue dye plus indocyanine green or radioisotope). After remove the SLNs and ALN, detection of the clipped node will be identified under mammography-guided. The clipped lymph node will be marked separately. All of the lymph node will be sent to pathologist for final examination.
Aim 2: Check the feasibility of SLNB after neoadjuvant CT
Hypothesis:
SLNB is feasible after neoadjuvant CT under certain circumstances.
Method:
The primary endpoints used for statistical analysis were the success rate for identifying and selectively removing the clipped node and the correlation of the response observed in the clipped node on pathology with the ALND specimen. The identification rate of the clipped node was analyzed in all patients who underwent surgical removal of the clipped node. Correlation between the pathologic response observed in the clipped node and in the ALND specimen was estimated using false-negative rates, sensitivity, specificity, positive predictive value, negative predictive value, and accuracy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clinical tumor stage 1-3 (cT1-3) and nodal stage 1 (cN1) breast cancer patients | – | Procedure: SLNB + ALNDPatients who will undergo neoadjuvant chemotherapy were asked to participate in this study. Informed consent will be given. Clip will be placed over the positive lymph node by surgeon which was proven by fine-needle aspiration cytology. After completion of neoadjuvant chemotherapy, surgery of the breast and the axilla was executed in the same session. Different surgeons performed the procedure. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Groups will be formed of the breast cancer patients who meet the eligible criteria
Key inclusion criteria (9 listed)
- Age ≥ 20 years.
- Female
- Primary breast cancer, not metastasis from other cancer.
- Histological subtypes: invasive ductal carcinoma.
- Clinical stage: cT1-3, cN1, cM0.
Key exclusion criteria (4 listed)
- Refuse to join the study.
- Unable to complete standard regimens of NCT.
- Metastasis in internal mammary nodes or other distant lymph nodes.
- Pregnancy
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 + ALNDPatients who received neoadjuvant chemotherapy will undergo SLNB+ALND to evaluate the feasibility of SLNB | Procedure or surgery | clinical tumor stage 1-3 (cT1-3) and nodal stage 1 (cN1) breast cancer patients |
Primary outcome
The impact of clipped lymph node in patients who received SLNB and ALND following neoadjuvant chemotherapy
Time frame: immediately after the surgery
compare the location of clipped lymph node in SLNB or ALND
1 secondary outcome
Correlation of the pathologic response observed in the clipped node and SLNB
Time frame: immediately after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- 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.
Loh principal investigator
National Cheng-Kung University 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 Breast Cancer and Sentinel Lymph Node Biopsy, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 9 inclusion and 4 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 2 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 Taiwan. 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?
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 impact of clipped lymph node in patients who received SLNB and ALND following neoadjuvant chemotherapy (time frame: immediately after the 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 2 Aug 2021.