Using vacuum-assisted biopsy to assess breast cancer response to chemotherapy before surgery
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
This study is testing whether a special biopsy method can help doctors see how well chemotherapy worked on breast cancer before surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Klinik Hirslanden, Zurich Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 26 sites (Salzburg and 25 other locations) |
| Trial ID | NCT04289935 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of vacuum-assisted biopsy (VAB) to evaluate the response of breast cancer patients to neoadjuvant chemotherapy (NAC) before surgery. The study aims to determine the diagnostic accuracy of VAB in detecting residual tumor tissue in patients who have shown a radiological complete response after NAC. By comparing VAB samples to those obtained during surgery, the trial seeks to improve the reliability of assessing treatment response and potentially guide surgical decisions. Participants will undergo VAB guided by ultrasound or mammography to obtain tissue samples from the tumor site.
Who should consider this trial
Good fit: Ideal candidates include adults with unifocal, histologically confirmed invasive breast cancer who have undergone neoadjuvant chemotherapy and achieved a radiological complete or near-complete response.
Not a fit: Patients with multifocal breast cancer or those who do not achieve a radiological response to neoadjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more accurate assessment of tumor response to chemotherapy, potentially leading to better surgical outcomes for breast cancer patients.
How similar studies have performed: While the use of VAB in this context is innovative, similar studies have shown promise in improving diagnostic accuracy for assessing treatment response in breast cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures * 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: * 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 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
Where this trial is running
Salzburg and 25 other locations
- Universitätsspital Salzburg — Salzburg, Austria (Not_yet_recruiting)
- Brustzentrum Schwaz — Schwaz, Austria (Recruiting)
- St. Josef Krankenhaus Wien — Vienna, Austria (Recruiting)
- Agaplesion Markus Krankenhaus — Frankfurt, Germany (Recruiting)
- Brustzentrum Heidelberg — Heidelberg, Germany (Recruiting)
- UFK Klinikum Südstadt Rostock — Rostock, Germany (Recruiting)
- Helios Universitätsklinikum Wuppertal — Wuppertal, Germany (Recruiting)
- Tumor Zentrum Aarau — Aarau, Switzerland (Recruiting)
- Kantonsspital Baden — Baden, Switzerland (Recruiting)
- Universitätsspital Basel — Basel, Switzerland (Recruiting)
- Bethesda Spital — Basel, Switzerland (Recruiting)
- St. Claraspital — Basel, Switzerland (Recruiting)
- Hirslanden Brustzentrum Bern Biel — Bern, Switzerland (Recruiting)
- Kantonsspital Graubünden — Chur, Switzerland (Recruiting)
- Spital Thurgau AG Frauenfeld und Münsterlingen — Frauenfeld, Switzerland (Recruiting)
- Clinique de Genolier — Genolier, Switzerland (Recruiting)
- Luzerner Kantonsspital — Lucerne, Switzerland (Recruiting)
- Hirslanden Klinik St. Anna — Lucerne, Switzerland (Recruiting)
- Ente Ospedaliero Cantonale, Dipartimento di ginecologia e ostretricia — Lugano, Switzerland (Recruiting)
- Brustzentrum Rheinfelden — Rheinfelden, Switzerland (Recruiting)
- Kantonsspital St. Gallen — Sankt Gallen, Switzerland (Recruiting)
- Tumor- und BrustZentrum Ostschweiz — Sankt Gallen, Switzerland (Recruiting)
- Kantonsspital Winterthur — Winterthur, Switzerland (Recruiting)
- Brust-Zentrum Seefeld — Zurich, Switzerland (Recruiting)
- Universitäts Spital Zürich — Zurich, Switzerland (Recruiting)
- Mediclinic City Hospital Dubai — Dubai, United Arab Emirates (Recruiting)
Study contacts
- Study coordinator: Daniel Tschopp
- Email: daniel.tschopp@hirslanden.ch
- Phone: +41 44 387 9545
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.