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

July 10, 2023 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Systemic neoadjuvant treatment was introduced in the 1990s (1,2) mainly for advanced (cT2, cT3) breast cancer to reduce the extent of disease and hence allow conservative surgery instead of mastectomy.

Studies (3-6) demonstrated that pathologic complete response (pCR) in the breast and/or axilla after neoadjuvant treatment predicted better overall survival (OS), better distant relapse-free survival (DRS), and lower mortality.

More recently, targeted neoadjuvant therapies achieve pCR in over 60% of patients (7,8) and in up to 70% of patients with HER2-positive or triple negative subtypes that are generally associated with poorer outcomes (9).

Ultrasound, mammography and magnetic resonance imaging are still imprecise in identifying surgically confirmed residual disease after neoadjuvant chemotherapy (10,11) and the sensitivity and specificity of these imaging techniques vary markedly, (12) so surgery remains the most reliable method of detecting any residual disease.

The aims of this study are

  1. to evaluate the ability of minimally invasive preoperative image-guided vacuum-assisted biopsy (VAB) to identify residual breast disease in breast cancer patients with either complete clinical/radiological complete response or with residual disease <1 cm after systemic neoadjuvant treatment; and
  2. to evaluate the ability of biopsy to identify residual axillary lymph node disease in patients who are cN1 pre-treatment and whose suspicious nodes are marked with a metal clip before treatment.

The VAB/needle biopsy results will be compared to pathological findings after quadrantectomy/mastectomy or surgical removal of the sentinel axillary lymph node(s) and tagged axillary lymph node(s) (if distinct from the sentinel node(s)).

This study is being conducted with a view to performing a future clinical trial on the omission of surgery in cases with clinical/radiological complete response and negative preoperative VAB.

Study Type

Observational

Enrollment (Estimated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
minimally invasive preoperative image-guided vacuum-assisted biopsy of the breast and needle biopsy of axillary lymph node
Other Names:
  • needle biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the accuracy of histological examination of the breast VAB performed pre-surgery
Time Frame: 40 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the accuracy of histological examination of the lymph node biopsy performed pre-surgery
Time Frame: 40 days
Identification of percentage of cases with correspondence between pre-operative biopsy findings in tagged cN1 axillary lymph nodes with histological findings after sentinel node biopsy and surgical removal of the tagged node/s (if different from the sentinel node(s)).
40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT 198/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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