Sentinel Lymph Node Biopsy in Clinically Node-negative Early Breast Cancer Patients After Neoadjuvant Chemotherapy

This is a prospective, single-center, non-randomized, non-controlled observational study.

Study Overview

• Status: Recruiting
• Conditions: Invasive Breast Cancer

Detailed Description

The panel of the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017 strongly believed that sentinel lymph node biopsy to be appropriate and favored the biopsy be carried out after neoadjuvant treatment in patients who presented with a clinically negative axilla and who received neoadjuvant treatment.

Patients with clinically node-negative early breast cancer treated in Breast Cancer Prevention and Treatment Center Peking University Cancer Hospital from February 2013 to August 2017 were retrospectively analyzed to investigate whether sentinel lymph node (SLN) biopsy after neoadjuvant chemotherapy can reduce the positive rate of SLN and the rate of axillary lymph node dissection (ALND). The study group underwent SLN biopsy after neoadjuvant chemotherapy, and the control group underwent SLN biopsy before chemotherapy. A total of 395 patients were eligible, including 85 in the study group and 310 in the control group. The detection rate of SLNs was 95.3% vs 98.7%（χ2 = 3.922，P = 0.069） in the study group compared with the control group, the positive rate of SLNs was 1.2% vs 18.6%（χ2 = 15.207，P = 0.000）, and the rate of ALND was 5.9% vs 15.2%（χ2 = 5.024，P = 0.025） in univariate analysis. Multivariate analysis showed that the study group had lower SLN positive rate (OR = 0.052, 95% CI: 0.0070 to 0.38, P = 0.004) and ALND rate (OR = 0.310, 95% CI: 0.118 to 0.812, P = 0.017). There was no statistically significant difference in detection rate of SLNs （OR = 0.244, 95% CI: 0.058 to 1.021, P = 0.053）between the two groups.

The aim of this study is to explore the detection rate and positive rate of sentinel lymph nodes, the rate of axillary lymph node dissection, and the proportion of patients with axillary lymph node metastases after neoadjuvant chemotherapy in patients with clinically node-negative early breast cancer. A mathematical model of axillary lymph node status will be established to predict axillary lymph node metastases.

• Study Type: Observational
• Enrollment (Anticipated): 348

Contacts and Locations

• Study Contact: Name: Qi-jun Zheng, MD; Phone Number: 8018 0086-10-88271119; Email: 13466552347@139.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Peking University Cancer Hospital
      • Contact: Qi-jun Zheng, MD; Phone Number: 8018 0086-10-88271119; Email: 13466552347@139.com
      • Principal Investigator: Qi-jun Zheng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Invasive breast cancer patients with clinically negtive axilla.

Description

Inclusion Criteria:

• Invasive breast cancer diagnosed with core needle needle biopsy;
• Staging cT1b-2N0M0;
• ER/PR positive cells ratio <10%, or HER2 positive (according to ASCO-CAP guidelines),and with chemotherapy indications;
• Without chemotherapy contraindications, and planned or has started neoadjuvant chemotherapy (HER2 positive breast cancer neoadjuvant anti-HER2 treatment, or have adjuvant anti-HER2 treatment plan);
• With axillary sentinel lymph node biopsy indications confirmed prior to neoadjuvant therapy;
• Voluntarily join the study and sign an informed consent form.

Exclusion Criteria:

• History of malignant tumors.
• With chemotherapy contraindications.
• Recieved any form of surgery of primary tumor or axillary lymph nodes.
• Refuse neoadjuvant chemotherapy.
• Refuse assessment examinations.
• Refuse to join the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
invasive breast cancer; Patients with invasive breast cancer who have clinically negative axilla and receive neoadjuvant treatment followed by sentinel lymph node biopsy are eligible for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Rate of Axillary Sentinel Lymph Nodes.	Positive rate of axillary sentinel lymph nodes in patients with clinically node-negative early breast cancer after neoadjuvant chemotherapy will be assessed.	Within 6 weeks after obtaining the post-surgery pathological results.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection Rate of Axillary Sentinel Lymph Nodes.	Detection rate of axillary sentinel lymph nodes in patients with clinically node-negative early breast cancer after neoadjuvant chemotherapy will be assessed.	Within 6 weeks after obtaining the post-surgery pathological results.
Rate of Axillary Lymph Node Dissection.	Rate of axillary lymph node dissection in patients with clinically node-negative early breast cancer after neoadjuvant chemotherapy will be assessed.	Within 6 weeks after obtaining the post-surgery pathological results.
Proportion of Patients with Axillary Lymph Node Metastases.	Proportion of patients with axillary lymph node metastases in patients with clinically node-negative early breast cancer after neoadjuvant chemotherapy will be assessed.	Within 6 weeks after obtaining the post-surgery pathological results.
Axillary Lymph Nodes Status Prediction Model.	A mathematical model of axillary lymph node status will be established to predict axillary lymph node metastases in patients with early stage axillary cancer after neoadjuvant chemotherapy.	Within 6 weeks after obtaining the post-surgery pathological results.

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Qi-jun Zheng, MD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 22, 2017
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 17, 2017
• First Posted (ACTUAL): December 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: neoadjuvant chemotherapy; Predictive model; axillary lymph node dissection; sentinel lymph node biopsy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BCP21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No