Current Value of Axillary Ultrasound in the Staging of Breast Cancer. Is BSGC Still Necessary?

• Conditions: Breast Cancer

• Registration Number: NCT03193008
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

AUS/FNAC allows the identification of tumors without axillary tumor involvement, or with low axillary tumor burden, many of which do not benefit from SLNB, in the staging of early breast cancer.

Objective: To calculate the negative predictive value of AUS/FNAC in those patients with breast cancer who meet ACOSOG Z0011 criteria.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-04-28
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-19
• Last Update Submitted: 2017-06-19
• Study First Posted: 2017-06-20
• Last Update Posted: 2017-06-20
• Primary Completion: 2017-07-15
• Study Completion: 2017-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1400

Inclusion Criteria

• Age ≥ 18 years
• Tumors with ACOSOG Z0011 criteria, except positive SLNB (cT1-T2; cN0; breast-conserving surgery; Whole-Breast Radiotherapy)
• Axillary study with AUS/FNAC.
• SLNB/ALND (Gold-Standard).

Exclusion Criteria

• Tumors without confirmation of axillary histologic status (No Gold-Standard)
• Tumor in pregnancy or breastfeeding.
• Tumors in the male.
• Tumors treated with neoadjuvant chemotherapy
• Tumors that do not meet ACOSOG Z0011 criteria.
• Tumors without axillary study using AUS/FNAC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of axillary tumor burden by axillary ultrasound	Two weeks after the axillary surgery	To calculate the negative predictive value of AUS/FNAC in those patients with breast cancer who meet ACOSOG Z0011 criteria.

Trial Locations

Locations (1)

Javier del Riego; 🇪🇸 Sabadell, Barcelona, Spain