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

Corporacion Parc Tauli

Status: Unknown

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03193008

CPT-JDR-2017-1

Details and patient eligibility

About

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.

Enrollment: 1,400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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