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Mini-invasive Detection of Residual Disease in Breast Cancer Patients in Remission After Primary Chemotherapy

NCT05951699 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2023-07-19

No results posted yet for this study

Summary

Breast surgery may be overtreatment when there is a complete response to systemic neoadjuvant treatment as determined clinically and by imaging. However the reliability of imaging techniques (ultrasound, mammography and magnetic resonance) in identifying complete response varies in published studies and surgery remains the preferred method of detecting residual disease.

The aims of this study are:

1. To assess the reliability of minimally invasive preoperative image-guided vacuum-assisted biopsy (VAB) in identifying residual breast in cT1-cT2-cT3, cN0-cN1 breast cancer patients, either with complete clinical/radiological response, or with residual breast disease \<1 cm, after systemic neoadjuvant treatment.
2. To assess the reliability of minimally invasive preoperative image-guided needle biopsy in identifying residual axillary disease in cT1-cT2-cT3, cN0-cN1 breast cancer patients, either with complete clinical/radiological response, or with residual breast disease \<1 cm, after systemic neoadjuvant treatment.

After neoadjuvant treatment, and evaluation with ultrasound, mammography and magnetic resonance, VAB will be performed on the breast, and needle biopsy will be performed on the axillary lymph node of pre-treatment cN1 cases, previously marked with a magnetic clip.

The biopsy findings will be compared with the surgical findings, consisting in quadrantectomy or mastectomy plus sentinel node biopsy (or separate removal of tagged lymph nodes if they do not coincide with the sentinel node(s)) to assess the ability of biopsy to identify residual disease.

Conditions

Interventions

DEVICE

minimally invasive preoperative image-guided vacuum-assisted biopsy

minimally invasive preoperative image-guided vacuum-assisted biopsy of the breast and needle biopsy of axillary lymph node

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Gabriele Martelli, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Via G. Venezian 1, 20133 Milan, Italy

Eligibility

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

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2025-12-31
Completion
2025-12-31

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 NCT05951699 on ClinicalTrials.gov