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Histology VABB-Histology Post Surgery Pilot Project (BETTY Trial)

NCT04365803 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2023-06-28

No results posted yet for this study

Summary

Pilot study on patients with invasive ductal breast cancer triple negative or receptor tyrosine-protein kinase erbB-2 (HER2) overexpressed, any axillary lymphnodes status (any cN), candidates to neoadjuvant chemotherapy.

The principal endpoint of the study will be the accuracy of the result of the histological examination of the Vacuum- Assisted Breast Biopsy (VABB) performed pre-surgery in comparison to the result of the histological examination of the definitive surgical intervention in patients with radiological complete response at Magnetic resonance imaging (MRI) done after the end of neoadjuvant chemotherapy.

Conditions

Interventions

PROCEDURE

vacuum-assisted breast biopsy

patient with radiological complete response after neoadjuvant chemotherapy undergo to vacuum assisted breast biopsy and the to definitive surgery

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Elisabetta Rossi, MD · European Institute of Oncology

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04365803 on ClinicalTrials.gov