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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06149377
• Other study ID #: NSFFP-2023Y0020
• Status: Completed
• Start date: April 1, 2012
• Est. completion date: May 31, 2023

Study information

• Verified date: December 2023
• Source: Fujian Medical University Union Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 716
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sentinel Lymph Node

Intervention

Procedure:
• Test cohort

Locations

Country	Name	City	State
China	Chuan Wang	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axillary pCR	the percent of patients who achieved axillary pathological complete response after NST.	10 years
Secondary	the False Negative Rate of SLNB	the percent of patients with residual lymph node disease were not identified.	12 months