Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer
NCT ID: NCT04289935
Last Updated: 2024-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
420 participants
INTERVENTIONAL
2020-08-17
2025-06-30
Brief Summary
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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.
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Detailed Description
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In general, it is difficult to predict pCR in the absence of invasive surgical techniques, as it depends on several factors such as biological subtype, the used chemotherapy regimen and anatomic stage. The most common imaging methods beside clinical examination are breast ultrasound, mammography and breast magnetic resonance imaging (MRI). As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this uncertainty, surgery (and the standardized assessment of resected tissue) 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.
The main objective of the trial is to determine the diagnostic accuracy of I-VAB using the full pathologic specimen evalutation obtained after open surgery to detect residual tissue.
Conditions
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Study Design
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NA
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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single arm
* Unicentric histologically confirmed invasive luminal B, HER2- enriched, triple negative breast cancer + Clipping + Neoadjuvant chemotherapy
* rCR / near-rCR in MRI / US
* Registration
* US-guided VAB
* Breast conserving surgery / mastectomy
* Pathology examination 1. Preoperative VAB, 2. Surgical specimen
Vacuum 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.
Interventions
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Vacuum 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.
Eligibility Criteria
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Inclusion Criteria
* unifocal, histologically confirmed invasive breast cancer with IHC luminal B (with or without overexpression or amplification of the HER2 receptor) and all ER negative (ER \< 10%) breast cancers
* Initial tumor size larger than 1 and less than 5 cm (cT1c to cT2), any N, M0
* Clipping of the primary tumor center prior to the start of neo-adjuvant chemotherapy
* Neo-adjuvant chemotherapy resulting in a radiological complete response or near complete response on MR-Imaging (confirmed within 28 days before or on registration) as described in the trial specific MR-Imaging instructions (available on the welcome page of the study specific SecuTrial link). MRI is strongly recommended, alternative ultrasound
* Former tumor bed must be accessible for biopsy
* Female or male aged ≥ 18 years
* Adequate condition for breast cancer surgery
* Patients with a previously treated malignancy are eligible, when the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low
Exclusion Criteria
* Multifocal/Multicentric breast cancer
* Inflammatory breast cancer
* Luminal-A types of breast cancers (ER ≥ 10% and PgR ≥ 10 % and G1 or 2, and/or Ki-67 ≤ 20%, HER2 negative) or low risk if assessed by a validated genomic prognostic test (e.g. Mammaprint, Endopredict, Oncotype or Nanostring)
* Distinct radiological sign of residual disease in the breast after neo-adjuvant chemotherapy by imaging
* Intra-/peritumoral microcalcifications larger than 2 cm at time of diagnosis
* Any local therapy (irradiation or surgery) to the currently treated breast prior to the trial intervention
* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, trial intervention and follow-up, affect patient compliance or place the patient at high risk from trial intervention-related complications
18 Years
ALL
No
Sponsors
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Oncoplastic Breast Consortium (OPBC)
UNKNOWN
Klinik Hirslanden, Zurich
OTHER
Responsible Party
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PD Dr. med. Christoph Tausch
Principal Investigator
Principal Investigators
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Christoph Tausch, MD
Role: STUDY_CHAIR
Brust-Zentrum, Zürich
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Andreas Sir, MD
Role: backup
Michael Hubalek, MD
Role: backup
Ulrich Schmidbauer, MD
Role: backup
Marc Thill, Prof.
Role: backup
Joerg Heil, Prof.
Role: backup
Steffi Hartmann, MD
Role: backup
Vesna Bjelic-Radisic, Prof.
Role: backup
Andreas Jakob, MD
Role: backup
Cornelia Leo, Prof
Role: backup
Christian Kurzeder, Prof
Role: backup
Dieter Müller, MD
Role: backup
Roberto Rodriguez, MD
Role: backup
Patrizia Sager, MD
Role: backup
Martina Maranta, MD
Role: backup
Mathias Fehr, Prof
Role: backup
Magdalena Kohlik, MD
Role: backup
Kathrin Schwedler, MD
Role: backup
Peter Dubsky, Prof
Role: backup
Maria Luisa Gasparri, Prof.
Role: backup
Maik Hauschild, MD
Role: backup
Christine Strub, MD
Role: backup
Michael Knauer, Prof
Role: backup
Denise Vorburger, MD
Role: backup
Christoph Tausch, MD
Role: backup
Heike Frauchiger-Heuer, MD
Role: backup
Annett Al Hamadi, MD
Role: backup
Other Identifiers
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HIRSLANDEN 01 OPBC SAKK 23/18
Identifier Type: -
Identifier Source: org_study_id
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