Prospective Clinical Trial to Assess a Mini-invasive Pre-surgical Procedure to Detect Residual Breast or Axillary Disease in Patients With cT1-T2-T3 cN0/N1 Breast Cancer in Complete Clinical/Radiological Remission After Primary Chemotherapy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Radiologically confirmed unifocal cT1-cT2-cT3 cN0-cN1 breast cancer patients indicated for primary chemotherapy

• Histologically confirmed HER2-positive, triple negative or luminal B HER2-positive invasive breast cancer

• Clinical/radiological complete response or residual breast disease \<1 cm after primary chemotherapy

• Absence of locoregional relapse or distant metastasis

• Signed informed consent to participate.

Locations
Other Locations
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Contact Information
Primary
Gabriele Martelli, MD
gabriele.martelli@istitutotumori.mi.it
+39 02 2390 3436
Backup
Chiara Listorti, MD
chiara.listorti@istitutotumori.mi.it
+39 02 2390 2169
Time Frame
Start Date: 2022-04-28
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 105
Treatments
minimally invasive preoperative image-guided vacuum-assisted biopsy
cT1-cT2-cT3 cN0-cN1 breast cancer patients, either with clinical/radiological complete response, or with \<1 cm residual breast disease after systemic primary treatment, undergo preoperative image-guided breast VAB with 9-gauge needle.~Patients who are cN1 before systemic primary treatment undergo removal of the tagged axillary nodes.~In both cases the aim is to identify any residual disease. Conservative breast surgery or mastectomy will be performed in all patients after multidisciplinary clinical evaluation.~Surgically confirmed residual tumor will be compared to VAB result.
Related Therapeutic Areas
Sponsors
Leads: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

This content was sourced from clinicaltrials.gov