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)
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| ClinicalTrials.gov Identifier: NCT04289935 |
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Recruitment Status :
Recruiting
First Posted : February 28, 2020
Last Update Posted : January 12, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Procedure: Vacuum assisted biopsy (VAB) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 420 participants |
| Allocation: | N/A |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | multicenter, prospective, single arm, feasibility trial |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| 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 |
| Actual Study Start Date : | August 17, 2020 |
| Estimated Primary Completion Date : | June 2025 |
| Estimated Study Completion Date : | June 2025 |
| Arm | Intervention/treatment |
|---|---|
Experimental: single arm
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Procedure: 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. |
- Sensitivity [ Time Frame: max. 6 weeks after registration ]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.
- Specificity [ Time Frame: max. 6 weeks after registration ]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) [ Time Frame: max. 6 weeks after registration ]PPV of I-VAB is defined as proportion of true positive patients given patients with non pCR assessed using VAB
- Negative predictive value (NPV) [ Time Frame: max. 6 weeks after registration ]NPV of I-VAB is defined as proportion of true negative patients given patients with pCR assessed using VAB
- Accuracy (ACC) [ Time Frame: max. 6 weeks after registration ]ACC of I-VAB is defined as the proportion of true positive and true negative patients.
- Surgical lymph node status [ Time Frame: max. 6 weeks after registration ]Surgical lymph node status (positive vs. negative) is categorized by the pathologist according to surgical specimen.
- Adverse events [ Time Frame: From US-guided VAB (max. 6 weeks after registration) until 2 weeks after breast surgery (max 1 day after VAB). ]Proportion of patients with bleeding/hematoma causing immediate surgical intervention and breast infection, which are related to VAB.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289935
| Contact: Daniel Tschopp | +41 44 387 9545 | daniel.tschopp@hirslanden.ch |
| Switzerland | |
| Tumor Zentrum Aarau | Recruiting |
| Aarau, Switzerland, 5000 | |
| Contact: Andreas Jakob, MD +41 62 836 78 30 andreas.jakob@tumor-zentrum.ch | |
| Principal Investigator: Andreas Jakob, MD | |
| Kantonsspital Baden | Recruiting |
| Baden, Switzerland, 5404 | |
| Contact: Cornelia Leo, Prof +41 56 486 35 14 cornelia.leo@ksb.ch | |
| Principal Investigator: Cornelia Leo, Prof | |
| Universitätsspital Basel | Recruiting |
| Basel, Switzerland, 4031 | |
| Contact: Christian Kurzeder, Prof +41 61 328 79 90 Christian.kurzeder@usb.ch | |
| Principal Investigator: Christian Kurzeder, Prof | |
| Bethesda Spital | Recruiting |
| Basel, Switzerland, 4052 | |
| Contact: Dieter Müller, MD +41 61 823 77 00 dieter.müller@hin.ch | |
| Principal Investigator: Dieter Müller, MD | |
| St. Claraspital | Recruiting |
| Basel, Switzerland | |
| Contact: Matthias Siebert, MD +41 61 685 89 09 matthias.siebert@claraspital.ch | |
| Principal Investigator: Matthias Siebert, MD | |
| Hirslanden Brustzentrum Bern Biel | Recruiting |
| Bern, Switzerland, 3013 | |
| Contact: Patrizia Sager, MD +41 31 337 89 70 patrizia.sager@hirslanden.ch | |
| Principal Investigator: Patrizia Sager, MD | |
| Kantonsspital Graubünden | Recruiting |
| Chur, Switzerland, 7000 | |
| Contact: Martina Gabriella Maranta, MD +41 81 254 81 64 martina.maranta@ksgr.ch | |
| Principal Investigator: Martina Maranta, MD | |
| Spital Thurgau AG Frauenfeld und Münsterlingen | Recruiting |
| Frauenfeld, Switzerland, 8501 | |
| Contact: Mathias Fehr, Prof +41 52 723 72 55 mathias.fehr@stgag.ch | |
| Principal Investigator: Mathias Fehr, Prof | |
| Clinique de Genolier | Recruiting |
| Genolier, Switzerland, 1272 | |
| Contact: Magdalena Kohlik, MD +41 22 366 93 67 mkohlik@genolier.net | |
| Principal Investigator: Magdalena Kohlik, MD | |
| Luzerner Kantonsspital | Recruiting |
| Luzern, Switzerland, 6000 | |
| Contact: Kathrin Schwedler, MD +41 41 205 12 36 kathrin.schwedler@luks.ch | |
| Principal Investigator: Kathrin Schwedler, MD | |
| Hirslanden Klinik St. Anna | Recruiting |
| Luzern, Switzerland, 6006 | |
| Contact: Peter Dubsky, Prof +41 41 208 37 54 peter.dubsky@hirslanden.ch | |
| Principal Investigator: Peter Dubsky, Prof | |
| Brustzentrum Rheinfelden | Recruiting |
| Rheinfelden, Switzerland, 4310 | |
| Contact: Maik Hauschild, MD +41 61 835 62 20 maik.hauschild@gzf.ch | |
| Principal Investigator: Maik Hauschild, MD | |
| Kantonsspital St. Gallen | Recruiting |
| St. Gallen, Switzerland, 9007 | |
| Contact: Christine Strub, MD +41 71 494 97 14 christine.strub@kssg.ch | |
| Principal Investigator: Christine Strub, MD | |
| Tumor- und BrustZentrum Ostschweiz | Recruiting |
| St. Gallen, Switzerland, 9016 | |
| Contact: Michael Knauer, Prof +41 71 552 33 33 michael.knauer@tbz-ost.ch | |
| Principal Investigator: Michael Knauer, Prof | |
| Kantonsspital Winterthur | Not yet recruiting |
| Winterthur, Switzerland, 8401 | |
| Contact: Daniela Hagen, MD +41 52 266 41 21 daniela.hagen@ksw.ch | |
| Principal Investigator: Daniela Hagen, MD | |
| Brust-Zentrum Seefeld | Recruiting |
| Zürich, Switzerland, 8008 | |
| Contact: Christoph Tausch, MD +41 44 533 81 00 c.tausch@brust-zentrum.ch | |
| Principal Investigator: Christoph Tausch, MD | |
| Study Chair: | Christoph Tausch, MD | Brust-Zentrum, Zürich |
| Responsible Party: | PD Dr. med. Christoph Tausch, Principal Investigator, Klinik Hirslanden, Zurich |
| ClinicalTrials.gov Identifier: | NCT04289935 |
| Other Study ID Numbers: |
HIRSLANDEN 01 SAKK 23/18 |
| First Posted: | February 28, 2020 Key Record Dates |
| Last Update Posted: | January 12, 2023 |
| Last Verified: | January 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Neoadjuvant chemotherapy VISION I breast cancer Vacuum assisted biopsy |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |