Impact of a Predictive Model on Sentinel Lymph Node Biopsy in Initially Lymph Node-positive, HER2-positive Breast Cancer

December 6, 2023 updated by: Chuan Wang, Fujian Medical University Union Hospital

Application of a Predictive Model on Sentinel Lymph Node Biopsy in Initially Lymph Node-positive, HER2-positive Breast Cancer After Neoadjuvant Systemic Therapy: a Multicenter Retrospective Study

The aim of the study was to develop and validate a nomogram to assess axillary pathological complete response (pCR) in patients with initially lymph node-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer and test its performance in guiding patient selection for sentinel lymph node biopsy (SLNB) following neoadjuvant systemic therapy (NST).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

We retrospectively reviewed the medical records of patients from Fujian Medical University Union Hospital (n = 386) as the training cohort and those from Fujian Cancer Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, and No. 900 Hospital of The Joint Logistic Support Force (n = 211) as an external validation cohort from April 1, 2012, to March 31, 2022. Additionally, 119 patients were enrolled as the test cohort to assess the predictive power of the model from May 1, 2022, to May 31, 2023.The inclusion criteria included: 1) histologically proven primary breast cancer without distant metastatic lesions, 2) HER2-positive status (defined as immunohistochemistry (IHC) of 3+ overexpression or 2+ expression, and a ratio of ≥ 2.0 by fluorescence in situ hybridization), 3) initial axillary lymph node-positive status confirmed using core- or fine-needle biopsy before NST, 4) a full course of standard neoadjuvant therapy before surgery, and 5) complete clinicopathological characteristics and treatment information. The study was approved by ethics committee of Fujian Medical University Union Hospital. All patients in the training and validation cohorts underwent mastectomy, breast-conserving surgery, radiation, and ALND surgery after completing NST. All patients in the additional independent cohort underwent SLNB followed by ALND, which detected at least 2 SLNs using methylene blue dye alone. SLNs were defined as blue-stained lymph nodes guided directly by blue-stained lymphatic vessels. Methylene blue dye was injected alone at peritumoral or subareolar sites 5-15 min before SLNB. After constructing the nomogram for predicting axillary pCR with the independent predictive factors, the investigators quantified the predictive performance of the model using the AUC of the receiver operating characteristic curve. Calibration plots with bootstrapping and the Hosmer-Lemeshow test were used to illustrate the calibration power of the model, with p > 0.05 indicating a good fit.20 The clinical utility of the model in guiding surgical options was evaluated using decision curve analysis by plotting net benefits.21 Internal validation was estimated using the bootstrap method. The investigators validated the nomogram using an external validation cohort from the other institutions. Following the Youden index, the investigators selected an optimal cutoff probability of predicting axillary pCR as a stratification criterion for identifying patients who underwent SLNB surgery after NST. The investigators additionally examined 119 patients who underwent SLNB with ≥ 2 SLNs removed, followed by ALND, as an independent cohort to evaluate the effect of the nomogram on identifying patients accurately. FNRs of SLNB were compared using two different strategies: performing SLNB in all patients without any selection criteria and performing SLNB in patients selected by the nomogram with the cutoff probability of axillary pCR. These results were compared with those of the two previous tests.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
716

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Chuan Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The investigators retrospectively reviewed the medical records of 597 patients at four institutions from April 1, 2012, to May 30, 2022. Patients from institution 1 (n = 386) served as the training cohort, whereas those from the other institutions (n = 211) served as an external validation cohort. A test cohort (n=119) who accepted SLNB followed ALND was collected to assess the predictive power of the model ，from June 1,2022 to We retrospectively reviewed the medical records of patients from Fujian Medical University Union Hospital (n = 386) as the training cohort and those from Fujian Cancer Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, and No. 900 Hospital of The Joint Logistic Support Force (n = 211) as an external validation cohort from April 1, 2012, to March 31, 2022. Additionally, 119 patients were enrolled as the test cohort to assess the predictive power of the model from May 1, 2022, to May 31, 2023.

Description

Inclusion Criteria:

  • histologically proven primary breast cancer without distant metastatic lesions,
  • HER2-positive status (defined as immunohistochemistry (IHC) of 3+ overexpression or 2+ expression, and a ratio of ≥ 2.0 by fluorescence in situ hybridization),
  • initial axillary lymph node-positive status confirmed using core- or fine-needle biopsy before NST,
  • a full course of standard neoadjuvant therapy before surgery
  • complete clinicopathological characteristics and treatment information.

Exclusion Criteria:

  • do not plan or are unable to operate;
  • with distant metastasis
  • do not accept full cycles or standard neoadjuvant systemic therapy
  • loss of clinicopathological characteristics and treatment information.
  • with serious cardiopulmonary diseases, uncontrolled infectious diseases and other non-tumor related diseases who could not tolerate comprehensive treatment such as surgery and chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Training cohort
Patients (n=386) who accepted neoadjuvant systemic therapy followed surgery were from fujian medical university union hospital from April 1, 2012, to May 30, 2022.
External validation cohort
Patients (n=211) who accepted neoadjuvant systemic therapy followed surgery were from Fujian Cancer Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University and No. 900 Hospital of The Joint Logistic Support Force from April 1, 2012, to May 30, 2022.
Test cohort
Patients (n=119) who accepted sentinel lymph node biopsy followed axillary lymph node dissection after neoadjuvant systemic therapy was retrospectively collected from June 1,2022 to May 31, 2023.
Procedure: Test cohort

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Axillary pCR
Time Frame: 10 years
the percent of patients who achieved axillary pathological complete response after NST.
10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the False Negative Rate of SLNB
Time Frame: 12 months
the percent of patients with residual lymph node disease were not identified.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Medical University Union Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: China Fujian, Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NSFFP-2023Y0020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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