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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)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Vacuum assisted biopsy (VAB)
Sponsored by
Klinik Hirslanden, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Neoadjuvant chemotherapy, VISION I, breast cancer, Vacuum assisted biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
  • unifocla, 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)
  • 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:

  • Metastatic breast cancer
  • 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 in MRI
  • 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
  • Contraindication for MRI
  • 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

Sites / Locations

  • Tumor Zentrum AarauRecruiting
  • Kantonsspital BadenRecruiting
  • Universitätsspital BaselRecruiting
  • Bethesda SpitalRecruiting
  • St. ClaraspitalRecruiting
  • Hirslanden Brustzentrum Bern BielRecruiting
  • Kantonsspital GraubündenRecruiting
  • Spital Thurgau AG Frauenfeld und MünsterlingenRecruiting
  • Clinique de GenolierRecruiting
  • Luzerner KantonsspitalRecruiting
  • Hirslanden Klinik St. AnnaRecruiting
  • Brustzentrum RheinfeldenRecruiting
  • Kantonsspital St. GallenRecruiting
  • Tumor- und BrustZentrum OstschweizRecruiting
  • Kantonsspital Winterthur
  • Brust-Zentrum SeefeldRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

Unicentric histologically confirmed invasive luminal B, HER2- enriched, triple negative breast cancer + Clipping + Neoadjuvant chemotherapy rCR / near-rCR in MRI Registration US-guided VAB Breast conserving surgery / mastectomy Pathology examination 1. Preoperative VAB, 2. Surgical specimen

Outcomes

Primary Outcome Measures

Sensitivity
Sensitivity of I-VAB is defined as proportion of true positive patients (Both VAB and surgery showing non pCR) given patients with non pCR assessed using surgical specimen.

Secondary Outcome Measures

Specificity
Specificity of I-VAB is defined as proportion of true negative patients (Both VAB and surgery showing pCR) given patients with pCR assessed using surgical specimen.
Positive predictive value (PPV)
PPV of I-VAB is defined as proportion of true positive patients given patients with non pCR assessed using VAB
Negative predictive value (NPV)
NPV of I-VAB is defined as proportion of true negative patients given patients with pCR assessed using VAB
Accuracy (ACC)
ACC of I-VAB is defined as the proportion of true positive and true negative patients.
Surgical lymph node status
Surgical lymph node status (positive vs. negative) is categorized by the pathologist according to surgical specimen.
Adverse events
Proportion of patients with bleeding/hematoma causing immediate surgical intervention and breast infection, which are related to VAB.

Full Information

First Posted
February 25, 2020
Last Updated
January 10, 2023
Sponsor
Klinik Hirslanden, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT04289935
Brief Title
Intelligent Vacuum Assisted Biopsy Immediately Before Surgery as an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer
Acronym
VISION I
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinik Hirslanden, Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Neoadjuvant chemotherapy (NAC), initially indicated to downstage tumors to achieve the option of breast conserving surgery, has lately become common practice in the primary treatment of breast cancer. The use of modern NAC regimens lead to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Neoadjuvant chemotherapy, VISION I, breast cancer, Vacuum assisted biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
multicenter, prospective, single arm, feasibility trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single arm
Arm Type
Experimental
Arm Description
Unicentric histologically confirmed invasive luminal B, HER2- enriched, triple negative breast cancer + Clipping + Neoadjuvant chemotherapy rCR / near-rCR in MRI Registration US-guided VAB Breast conserving surgery / mastectomy Pathology examination 1. Preoperative VAB, 2. Surgical specimen
Intervention Type
Procedure
Intervention Name(s)
Vacuum assisted biopsy (VAB)
Intervention Description
The trial intervention consists of a diagnostic interventional procedure, US-guided or mammographically guided VAB post-NAC, prior to the standard breast surgery.
Primary Outcome Measure Information:
Title
Sensitivity
Description
Sensitivity of I-VAB is defined as proportion of true positive patients (Both VAB and surgery showing non pCR) given patients with non pCR assessed using surgical specimen.
Time Frame
max. 6 weeks after registration
Secondary Outcome Measure Information:
Title
Specificity
Description
Specificity of I-VAB is defined as proportion of true negative patients (Both VAB and surgery showing pCR) given patients with pCR assessed using surgical specimen.
Time Frame
max. 6 weeks after registration
Title
Positive predictive value (PPV)
Description
PPV of I-VAB is defined as proportion of true positive patients given patients with non pCR assessed using VAB
Time Frame
max. 6 weeks after registration
Title
Negative predictive value (NPV)
Description
NPV of I-VAB is defined as proportion of true negative patients given patients with pCR assessed using VAB
Time Frame
max. 6 weeks after registration
Title
Accuracy (ACC)
Description
ACC of I-VAB is defined as the proportion of true positive and true negative patients.
Time Frame
max. 6 weeks after registration
Title
Surgical lymph node status
Description
Surgical lymph node status (positive vs. negative) is categorized by the pathologist according to surgical specimen.
Time Frame
max. 6 weeks after registration
Title
Adverse events
Description
Proportion of patients with bleeding/hematoma causing immediate surgical intervention and breast infection, which are related to VAB.
Time Frame
From US-guided VAB (max. 6 weeks after registration) until 2 weeks after breast surgery (max 1 day after VAB).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures unifocla, 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) 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: Metastatic breast cancer 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 in MRI 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 Contraindication for MRI 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Tschopp
Phone
+41 44 387 9545
Email
daniel.tschopp@hirslanden.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Tausch, MD
Organizational Affiliation
Brust-Zentrum, Zürich
Official's Role
Study Chair
Facility Information:
Facility Name
Tumor Zentrum Aarau
City
Aarau
ZIP/Postal Code
5000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Jakob, MD
Phone
+41 62 836 78 30
Email
andreas.jakob@tumor-zentrum.ch
First Name & Middle Initial & Last Name & Degree
Andreas Jakob, MD
Facility Name
Kantonsspital Baden
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cornelia Leo, Prof
Phone
+41 56 486 35 14
Email
cornelia.leo@ksb.ch
First Name & Middle Initial & Last Name & Degree
Cornelia Leo, Prof
Facility Name
Universitätsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Kurzeder, Prof
Phone
+41 61 328 79 90
Email
Christian.kurzeder@usb.ch
First Name & Middle Initial & Last Name & Degree
Christian Kurzeder, Prof
Facility Name
Bethesda Spital
City
Basel
ZIP/Postal Code
4052
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dieter Müller, MD
Phone
+41 61 823 77 00
Email
dieter.müller@hin.ch
First Name & Middle Initial & Last Name & Degree
Dieter Müller, MD
Facility Name
St. Claraspital
City
Basel
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Siebert, MD
Phone
+41 61 685 89 09
Email
matthias.siebert@claraspital.ch
First Name & Middle Initial & Last Name & Degree
Matthias Siebert, MD
Facility Name
Hirslanden Brustzentrum Bern Biel
City
Bern
ZIP/Postal Code
3013
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizia Sager, MD
Phone
+41 31 337 89 70
Email
patrizia.sager@hirslanden.ch
First Name & Middle Initial & Last Name & Degree
Patrizia Sager, MD
Facility Name
Kantonsspital Graubünden
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Gabriella Maranta, MD
Phone
+41 81 254 81 64
Email
martina.maranta@ksgr.ch
First Name & Middle Initial & Last Name & Degree
Martina Maranta, MD
Facility Name
Spital Thurgau AG Frauenfeld und Münsterlingen
City
Frauenfeld
ZIP/Postal Code
8501
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathias Fehr, Prof
Phone
+41 52 723 72 55
Email
mathias.fehr@stgag.ch
First Name & Middle Initial & Last Name & Degree
Mathias Fehr, Prof
Facility Name
Clinique de Genolier
City
Genolier
ZIP/Postal Code
1272
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Kohlik, MD
Phone
+41 22 366 93 67
Email
mkohlik@genolier.net
First Name & Middle Initial & Last Name & Degree
Magdalena Kohlik, MD
Facility Name
Luzerner Kantonsspital
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathrin Schwedler, MD
Phone
+41 41 205 12 36
Email
kathrin.schwedler@luks.ch
First Name & Middle Initial & Last Name & Degree
Kathrin Schwedler, MD
Facility Name
Hirslanden Klinik St. Anna
City
Luzern
ZIP/Postal Code
6006
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Dubsky, Prof
Phone
+41 41 208 37 54
Email
peter.dubsky@hirslanden.ch
First Name & Middle Initial & Last Name & Degree
Peter Dubsky, Prof
Facility Name
Brustzentrum Rheinfelden
City
Rheinfelden
ZIP/Postal Code
4310
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maik Hauschild, MD
Phone
+41 61 835 62 20
Email
maik.hauschild@gzf.ch
First Name & Middle Initial & Last Name & Degree
Maik Hauschild, MD
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Strub, MD
Phone
+41 71 494 97 14
Email
christine.strub@kssg.ch
First Name & Middle Initial & Last Name & Degree
Christine Strub, MD
Facility Name
Tumor- und BrustZentrum Ostschweiz
City
St. Gallen
ZIP/Postal Code
9016
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Knauer, Prof
Phone
+41 71 552 33 33
Email
michael.knauer@tbz-ost.ch
First Name & Middle Initial & Last Name & Degree
Michael Knauer, Prof
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Hagen, MD
Phone
+41 52 266 41 21
Email
daniela.hagen@ksw.ch
First Name & Middle Initial & Last Name & Degree
Daniela Hagen, MD
Facility Name
Brust-Zentrum Seefeld
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Tausch, MD
Phone
+41 44 533 81 00
Email
c.tausch@brust-zentrum.ch
First Name & Middle Initial & Last Name & Degree
Christoph Tausch, MD

12. IPD Sharing Statement

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

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