NCT03193008

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2017

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

4 months

First QC Date

April 28, 2017

Last Update Submit

June 19, 2017

Conditions

Breast Cancer

Keywords

Breast CancerAxillary ultrasoundSentinel lymph node biopsyAxillary management

Outcome Measures

Primary Outcomes (1)

  • 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.

    Two weeks after the axillary surgery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with histologically confirmed breast cancer from January 2008 to December 2013

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Javier del Riego

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 28, 2017

First Posted

June 20, 2017

Study Start

April 1, 2017

Primary Completion

July 15, 2017

Study Completion

July 15, 2017

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)