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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.
Show all 9Show fewer
  • 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.

Taiwan1 site
  • National Cheng Kung University Hospital

    Tainan, 704

Other trials in Taiwan

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 groups in NCT04986306
Study groupRoleWhat they receive
clinical tumor stage 1-3 (cT1-3) and nodal stage 1 (cN1) breast cancer patientsPatients 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.

  1. 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)
  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.

  1. First posted2 Aug 2021
  2. Study start20 May 2021
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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
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

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.

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