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

NCT05951699 | Unknown

• 1 other identifier: INT 198/21
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Breast Cancer

Keywords

Breast cancer; Neoadjuvant chemotherapy; vacuum-assisted biopsy

Outcome Measures

Primary Outcomes (1)

• Evaluation of the accuracy of histological examination of the breast VAB performed pre-surgery

  Identification of percentage of cases with correspondence between pre-operative VAB findings in breast with histological findings after quadrantectomy or mastectomy in patients with complete radiological response after neoadjuvant chemotherapy.

  40 days

Secondary Outcomes (1)

• Evaluation of the accuracy of histological examination of the lymph node biopsy performed pre-surgery

  40 days

Study Arms (1)

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.

Device: minimally invasive preoperative image-guided vacuum-assisted biopsy

Interventions

minimally invasive preoperative image-guided vacuum-assisted biopsy DEVICE

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

Also known as: needle biopsy

minimally invasive preoperative image-guided vacuum-assisted biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Disease surgically inoperable or surgery not performed
• Multifocal disease or presence of microcalcifications at imaging.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Related Publications (14)

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy, Needle

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Gabriele Martelli, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Via G. Venezian 1, 20133 Milan, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriele Martelli, MD

CONTACT

+39 02 2390 3436; gabriele.martelli@istitutotumori.mi.it

Chiara Listorti, MD

CONTACT

+39 02 2390 2169; chiara.listorti@istitutotumori.mi.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: July 19, 2023
• Study Start: April 28, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 19, 2023

Record last verified: 2023-05

Locations

IT (1)