Actively Recruiting
Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer
Led by Klinik Hirslanden, Zurich · Updated on 2024-10-23
420
Participants Needed
26
Research Sites
249 weeks
Total Duration
On this page
Sponsors
K
Klinik Hirslanden, Zurich
Lead Sponsor
O
Oncoplastic Breast Consortium (OPBC)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent according to ICH/GCP before registration and any trial procedures
- Unifocal, histologically confirmed invasive breast cancer with IHC luminal B or ER negative (ER < 10%) breast cancers
- Initial tumor size larger than 1 cm and less than 5 cm (cT1c to cT2), any lymph node status, no distant metastasis (M0)
- Clipping of the primary tumor center before starting neoadjuvant chemotherapy
- Radiological complete or near complete response on MRI (or ultrasound if MRI not available) confirmed within 28 days before or on registration
- Former tumor bed must be accessible for biopsy
- Female or male aged 18 years or older
- Suitable condition for breast cancer surgery
- Patients with previously treated cancer eligible if low risk of interference with study safety or efficacy
You will not qualify if you...
- Metastatic breast cancer
- Multifocal or multicentric breast cancer
- Inflammatory breast cancer
- Luminal-A breast cancers (ER ≥ 10% and PgR ≥ 10% and grade 1 or 2, and/or Ki-67 ≤ 20%, HER2 negative) or low risk by validated genomic test
- Clear radiological signs of residual disease after neoadjuvant chemotherapy
- Intra- or peritumoral microcalcifications larger than 2 cm at diagnosis
- Any prior local therapy like irradiation or surgery to the breast currently treated before trial intervention
- Any serious medical, psychiatric, psychological, family, or geographical condition that may interfere with staging, intervention, follow-up, compliance, or increase risk from trial procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Universitätsspital Salzburg
Salzburg, Austria, 5020
Not Yet Recruiting
2
Brustzentrum Schwaz
Schwaz, Austria, 6130
Actively Recruiting
3
St. Josef Krankenhaus Wien
Vienna, Austria, 1130
Actively Recruiting
4
Agaplesion Markus Krankenhaus
Frankfurt, Germany, 60431
Actively Recruiting
5
Brustzentrum Heidelberg
Heidelberg, Germany, 69121
Actively Recruiting
6
UFK Klinikum Südstadt Rostock
Rostock, Germany, 18059
Actively Recruiting
7
Helios Universitätsklinikum Wuppertal
Wuppertal, Germany, 42283
Actively Recruiting
8
Tumor Zentrum Aarau
Aarau, Switzerland, 5000
Actively Recruiting
9
Kantonsspital Baden
Baden, Switzerland, 5404
Actively Recruiting
10
Universitätsspital Basel
Basel, Switzerland, 4031
Actively Recruiting
11
Bethesda Spital
Basel, Switzerland, 4052
Actively Recruiting
12
St. Claraspital
Basel, Switzerland
Actively Recruiting
13
Hirslanden Brustzentrum Bern Biel
Bern, Switzerland, 3013
Actively Recruiting
14
Kantonsspital Graubünden
Chur, Switzerland, 7000
Actively Recruiting
15
Spital Thurgau AG Frauenfeld und Münsterlingen
Frauenfeld, Switzerland, 8501
Actively Recruiting
16
Clinique de Genolier
Genolier, Switzerland, 1272
Actively Recruiting
17
Luzerner Kantonsspital
Lucerne, Switzerland, 6000
Actively Recruiting
18
Hirslanden Klinik St. Anna
Lucerne, Switzerland, 6006
Actively Recruiting
19
Ente Ospedaliero Cantonale, Dipartimento di ginecologia e ostretricia
Lugano, Switzerland, 6962
Actively Recruiting
20
Brustzentrum Rheinfelden
Rheinfelden, Switzerland, 4310
Actively Recruiting
21
Kantonsspital St. Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
22
Tumor- und BrustZentrum Ostschweiz
Sankt Gallen, Switzerland, 9016
Actively Recruiting
23
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Actively Recruiting
24
Brust-Zentrum Seefeld
Zurich, Switzerland, 8008
Actively Recruiting
25
Universitäts Spital Zürich
Zurich, Switzerland, 8091
Actively Recruiting
26
Mediclinic City Hospital Dubai
Dubai, United Arab Emirates
Actively Recruiting
Research Team
D
Daniel Tschopp
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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