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

N/AUnknownNCT03193008

Corporacion Parc Tauli1,400 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,400

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Javier del Riego

Sabadell, Barcelona, Spain

Outcomes

Primary Outcomes

Detection of axillary tumor burden by axillary ultrasound

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

Time frame: Two weeks after the axillary surgery

Data from ClinicalTrials.gov

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