Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound

• Conditions: Breast Cancer Female

• Registration Number: NCT02992769
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

Axillary lymph node status is a vital prognostic factors in breast cancer patients and provides crucial information for making treatment decisions.This projective observational study is planned to identify risk factors for axillary metastases in breast cancer patients with axillary ultrasound and to construct a nomogram to predict the risk of axillary metastases in these patients.

Detailed Description

Breast carcinoma is the most common malignancy in women, accounting for 25% of all female cancer cases and 15% of all cancer-related deaths in the world.Lymph node metastasis is a multifactorial event. Among patients with a preoperative axillary ultrasound, almost 40% of patients are pathologically proved to be free from axillary metastasis.The purpose of this study is to develop a nomogram to evaluate the probability of axillary metastasis as a tool to support clinical decision-making.

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-12
• Study First Submitted: 2016-12-11
• Study First Submitted QC: 2016-12-11
• Study First Posted: 2016-12-14
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• female patients with primary breast cancer
• receiving a successful SLNB or ALND
• pathological diagnosed, without distant metastasis
• a clinically negative axilla

Exclusion Criteria

• pregnancy
• neoadjuvant therapy
• previous ipsilateral axillary surgery
• inflammatory breast cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Axillary Metastases	4 months to 1.5 year	Surgical treatment for breast cancer patients include breast-conserving surgery or mastectomy with or without breast reconstruction. Intraoperative ALND is carried out when the SLNs are positive by intraoperative frozen section. Post-operative H\&E permanent staining is administered to confirm the results of the frozen section. Serial H\&E and immunohistochemistry stain (IHC) are only carried out when axillary metastases are not visible after H\&E staining.

Trial Locations

Locations (1)

Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China