RecruitingNot ApplicableNCT04289935

Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer

Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer (VISION I): a Multicenter Prospective Feasibility Trial

Sponsor

Klinik Hirslanden, Zurich

Enrollment

420 participants

Start Date

Aug 17, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

Neoadjuvant chemotherapy (NAC) is common practice in the primary treatment of breast cancer, leading to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this uncertainty, surgery is so far the only valid option to either ascertain complete response or to remove the complete residual disease. Vacuum-assisted biopsy (VAB) with the possibility of obtaining tissue of the former tumor center could contribute more reliably to detect any residual tumor or respectively, rule out residual disease. Ultrasound (US) or mammographically (MG) guided VAB will be used in this trial in order to detect residual tumor lesions in patients with radiological complete response (rCR) after NAC. The investigators will evaluate the diagnostic accuracy of the post-NAC VAB sample in comparison to the sample obtained in open surgery.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether a vacuum-assisted biopsy (a minimally invasive tissue sampling procedure) done just before surgery can accurately show whether a breast cancer has fully responded to pre-surgery chemotherapy. The goal is to give doctors a better picture of how well the treatment has worked before removing the breast tumor. **You may be eligible if...** - You have been diagnosed with invasive breast cancer — either a specific hormonal subtype (Luminal B) or any estrogen receptor-negative breast cancer - Your tumor is between 1 and 5 cm and has not spread to distant organs - You are scheduled to receive chemotherapy before surgery (neoadjuvant chemotherapy) - A clip was placed to mark your tumor before chemotherapy began **You may NOT be eligible if...** - Your tumor is smaller than 1 cm or larger than 5 cm - You have inflammatory breast cancer or distant metastases - Your cancer does not fit the required hormonal subtypes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREVacuum assisted biopsy (VAB)

The trial intervention consists of a diagnostic interventional procedure, US-guided or mammographically guided VAB post-NAC, prior to the standard breast surgery.

Locations(26)

Universitätsspital Salzburg

Salzburg, Austria

Brustzentrum Schwaz

Schwaz, Austria

St. Josef Krankenhaus Wien

Vienna, Austria

Agaplesion Markus Krankenhaus

Frankfurt, Germany

Brustzentrum Heidelberg

Heidelberg, Germany

UFK Klinikum Südstadt Rostock

Rostock, Germany

Helios Universitätsklinikum Wuppertal

Wuppertal, Germany

Tumor Zentrum Aarau

Aarau, Switzerland

Kantonsspital Baden

Baden, Switzerland

Universitätsspital Basel

Basel, Switzerland

Bethesda Spital

Basel, Switzerland

St. Claraspital

Basel, Switzerland

Hirslanden Brustzentrum Bern Biel

Bern, Switzerland

Kantonsspital Graubünden

Chur, Switzerland

Spital Thurgau AG Frauenfeld und Münsterlingen

Frauenfeld, Switzerland

Clinique de Genolier

Genolier, Switzerland

Luzerner Kantonsspital

Lucerne, Switzerland

Hirslanden Klinik St. Anna

Lucerne, Switzerland

Ente Ospedaliero Cantonale, Dipartimento di ginecologia e ostretricia

Lugano, Switzerland

Brustzentrum Rheinfelden

Rheinfelden, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Tumor- und BrustZentrum Ostschweiz

Sankt Gallen, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland

Brust-Zentrum Seefeld

Zurich, Switzerland

Universitäts Spital Zürich

Zurich, Switzerland

Mediclinic City Hospital Dubai

Dubai, United Arab Emirates

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NCT04289935

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