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

NCT06149377 | Completed

• 1 other identifier: NSFFP-2023Y0020
• Study Type: observational
• Target: 716
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Breast Cancer; Sentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

• Axillary pCR

  the percent of patients who achieved axillary pathological complete response after NST.

  10 years

Secondary Outcomes (1)

• the False Negative Rate of SLNB

  12 months

Study Arms (3)

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

Interventions

Test cohort PROCEDURE

Test cohort

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Chuan Wang

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• China Fujian

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of breast surgery

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 29, 2023
• Study Start: April 1, 2012
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

CN (1)