Intelligent Vacuum-assisted Breast Biopsy Before Tumor Surgery to Determine the Success of Prior Chemotherapy
Summary description of the study
Some patients with breast cancer receive chemotherapy before tumor surgery to shrink the tumor. Sometimes this chemotherapy works so well that the tumor is no longer detectable by imaging after treatment. To ensure that the tumor has completely disappeared, a breast surgery is performed on the patients. This involves removing at least part of the original tumor tissue, which is now only scar tissue as a result of the chemotherapy.
Experts suspect that for some of these patients, surgery may not be necessary if it could instead be confirmed through a biopsy (tissue sampling using a hollow needle) that the tumor cells have completely disappeared.
We want to investigate in this study, as a first step, whether this assumption is correct. To do this, we need to answer the question of whether, after chemotherapy, vacuum-assisted biopsy and subsequent examination of the tissue can reliably determine whether there are no tumor cells left in the breast, as effectively as a tumor surgery. If this is the case, these patients could avoid surgery with all its risks and side effects (such as scarring).
(BASEC)
Intervention under investigation
Biopsy of tumor tissue
(BASEC)
Disease under investigation
Determining the success of prior chemotherapy in breast cancer
(BASEC)
Women and men over 18 years old can participate in the study. Participants are affected by certain types of breast cancer with a tumor size of 1-5 cm and without metastases. After chemotherapy, no or almost no tumor tissue can be detected in the participants by imaging. The health status of the participants must be good enough for them to undergo surgery.
(BASEC)
Exclusion criteria
- Metastatic breast cancer
- Multicentric breast cancer
- Inflammatory breast cancer
(BASEC)
Trial sites
Aarau, Basel, Bern, Chur, Geneva, Lugano, Luzern, St. Gallen, Winterthur, Zurich, Other
(BASEC)
Baden, Genolier, Grabs, Rheinfelden, Frauenfeld, Münsterlingen
(BASEC)
Sponsor
Klinik Hirslanden
(BASEC)
Contact
Contact Person Switzerland
Daniel Tschopp
+41 44 387 95 45
ClinicalTrialUnit@clutterhirslanden.chKlinik Hirslanden Witellikerstrasse 40 CH-8152 Zürich
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
11.06.2020
(BASEC)
ICTRP Trial ID
NCT04289935 (ICTRP)
Official title (approved by ethics committee)
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 (BASEC)
Academic 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 (ICTRP)
Public title
Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer (ICTRP)
Disease under investigation
Breast Cancer
(ICTRP)
Intervention under investigation
Procedure: Vacuum assisted biopsy (VAB)
(ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
(ICTRP)
Inclusion/Exclusion criteria
Gender: All<br>Maximum age: N/A<br>Minimum age: 18 Years<br>Inclusion Criteria:<br><br> - Written informed consent according to ICH/GCP regulations before registration and<br> prior to any trial specific procedures<br><br> - unifocal, histologically confirmed invasive breast cancer with IHC luminal B (with<br> or without overexpression or amplification of the HER2 receptor) and all ER negative<br> (ER < 10%) breast cancers<br><br> - Initial tumor size larger than 1 and less than 5 cm (cT1c to cT2), any N, M0<br><br> - Clipping of the primary tumor center prior to the start of neo-adjuvant chemotherapy<br><br> - Neo-adjuvant chemotherapy resulting in a radiological complete response or near<br> complete response on MR-Imaging (confirmed within 28 days before or on registration)<br> as described in the trial specific MR-Imaging instructions (available on the welcome<br> page of the study specific SecuTrial link). MRI is strongly recommended, alternative<br> ultrasound<br><br> - Former tumor bed must be accessible for biopsy<br><br> - Female or male aged = 18 years<br><br> - Adequate condition for breast cancer surgery<br><br> - Patients with a previously treated malignancy are eligible, when the risk of the<br> prior malignancy interfering with either safety or efficacy endpoints is very low<br><br>Exclusion criteria:<br><br> - Metastatic breast cancer<br><br> - Multifocal/Multicentric breast cancer<br><br> - Inflammatory breast cancer<br><br> - Luminal-A types of breast cancers (ER = 10% and PgR = 10 % and G1 or 2, and/or Ki-67<br> = 20%, HER2 negative) or low risk if assessed by a validated genomic prognostic test<br> (e.g. Mammaprint, Endopredict, Oncotype or Nanostring)<br><br> - Distinct radiological sign of residual disease in the breast after neo-adjuvant<br> chemotherapy by imaging<br><br> - Intra-/peritumoral microcalcifications larger than 2 cm at time of diagnosis<br><br> - Any local therapy (irradiation or surgery) to the currently treated breast prior to<br> the trial intervention<br><br> - Any other serious underlying medical, psychiatric, psychological, familial or<br> geographical condition, which in the judgment of the investigator may interfere with<br> the planned staging, trial intervention and follow-up, affect patient compliance or<br> place the patient at high risk from trial intervention-related complications
(ICTRP)
not available
Primary and secondary end points
Sensitivity
(ICTRP)
Specificity;Positive predictive value (PPV);Negative predictive value (NPV);Accuracy (ACC);Surgical lymph node status;Adverse events
(ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Oncoplastic Breast Consortium (OPBC) (ICTRP)
Additional contacts
Christoph Tausch, MD;Daniel Tschopp, daniel.tschopp@hirslanden.ch, +41 44 387 9545, Brust-Zentrum, Z?rich, (ICTRP)
Secondary trial IDs
HIRSLANDEN 01 OPBC SAKK 23/18 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04289935 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available