NCT04289935Recruiting
Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer
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.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- No phase (N/A)
- Study type
- Interventional
- Countries
- Switzerland, Germany, Austria, United Arab Emirates
- Sponsor
- Klinik Hirslanden, Zurich(Other)
- Protocol no.
- HIRSLANDEN 01 OPBC SAKK 23/18
- Conditions
- Breast Cancer
- Interventions
- Procedure
Treatments studied
- Vacuum assisted biopsy (VAB)
Collaborators
Oncoplastic Breast Consortium (OPBC)
Locations · 25
- Aarau, SwitzerlandTumor Zentrum AarauRecruiting at this site
- Baden, SwitzerlandKantonsspital BadenRecruiting at this site
- Basel, SwitzerlandUniversitätsspital BaselRecruiting at this site
- Basel, SwitzerlandBethesda SpitalRecruiting at this site
- Basel, SwitzerlandSt. ClaraspitalRecruiting at this site
- Bern, SwitzerlandHirslanden Brustzentrum Bern BielRecruiting at this site
- Chur, SwitzerlandKantonsspital GraubündenRecruiting at this site
- Frauenfeld, SwitzerlandSpital Thurgau AG Frauenfeld und MünsterlingenRecruiting at this site
- Genolier, SwitzerlandClinique de GenolierRecruiting at this site
- Lucerne, SwitzerlandLuzerner KantonsspitalRecruiting at this site
- Lucerne, SwitzerlandHirslanden Klinik St. AnnaRecruiting at this site
- Lugano, SwitzerlandEnte Ospedaliero Cantonale, Dipartimento di ginecologia e ostretriciaRecruiting at this site
- Rheinfelden, SwitzerlandBrustzentrum RheinfeldenRecruiting at this site
- Sankt Gallen, SwitzerlandKantonsspital St. GallenRecruiting at this site
- Sankt Gallen, SwitzerlandTumor- und BrustZentrum OstschweizRecruiting at this site
- Winterthur, SwitzerlandKantonsspital WinterthurRecruiting at this site
- Zurich, SwitzerlandBrust-Zentrum SeefeldRecruiting at this site
- Zurich, SwitzerlandUniversitäts Spital ZürichRecruiting at this site
- Frankfurt, GermanyAgaplesion Markus KrankenhausRecruiting at this site
- Heidelberg, GermanyBrustzentrum HeidelbergRecruiting at this site
- Rostock, GermanyUFK Klinikum Südstadt RostockRecruiting at this site
- Wuppertal, GermanyHelios Universitätsklinikum WuppertalRecruiting at this site
- Schwaz, AustriaBrustzentrum SchwazRecruiting at this site
- Vienna, AustriaSt. Josef Krankenhaus WienRecruiting at this site
- Dubai, United Arab EmiratesMediclinic City Hospital DubaiRecruiting at this site
In total, worldwide, 25 of the 26 sites listed in the registry are recruiting; the other one is not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 23, 2024).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.