A Nomogram to Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Axillary Metastases
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Axillary Metastases
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Fengyan Yu
Principal Investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University