NCT04289935Recrutement en cours

Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer

Résumé

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.

Critères d'inclusion

• 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

Critères d'exclusion

• 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

Les coordonnées de l'équipe de l'essai s'affichent sur demande.

Voir la fiche officielle de l'essai

Statut: Recrutement en cours
Phase: Sans phase (N/A)
Type d'étude: Interventionnelle
Pays: Suisse, Allemagne, Autriche, Émirats arabes unis
Promoteur: Klinik Hirslanden, Zurich(Autre)
N° de protocole: HIRSLANDEN 01 OPBC SAKK 23/18
Pathologies: Breast Cancer
Interventions: Procédure

Traitements évalués

Vacuum assisted biopsy (VAB)

Collaborateurs

Oncoplastic Breast Consortium (OPBC)

Lieux · 25

Aarau, SuisseTumor Zentrum AarauRecrute dans ce centre
Baden, SuisseKantonsspital BadenRecrute dans ce centre
Basel, SuisseUniversitätsspital BaselRecrute dans ce centre
Basel, SuisseBethesda SpitalRecrute dans ce centre
Basel, SuisseSt. ClaraspitalRecrute dans ce centre
Bern, SuisseHirslanden Brustzentrum Bern BielRecrute dans ce centre
Chur, SuisseKantonsspital GraubündenRecrute dans ce centre
Frauenfeld, SuisseSpital Thurgau AG Frauenfeld und MünsterlingenRecrute dans ce centre
Genolier, SuisseClinique de GenolierRecrute dans ce centre
Lucerne, SuisseLuzerner KantonsspitalRecrute dans ce centre
Lucerne, SuisseHirslanden Klinik St. AnnaRecrute dans ce centre
Lugano, SuisseEnte Ospedaliero Cantonale, Dipartimento di ginecologia e ostretriciaRecrute dans ce centre
Rheinfelden, SuisseBrustzentrum RheinfeldenRecrute dans ce centre
Sankt Gallen, SuisseKantonsspital St. GallenRecrute dans ce centre
Sankt Gallen, SuisseTumor- und BrustZentrum OstschweizRecrute dans ce centre
Winterthur, SuisseKantonsspital WinterthurRecrute dans ce centre
Zurich, SuisseBrust-Zentrum SeefeldRecrute dans ce centre
Zurich, SuisseUniversitäts Spital ZürichRecrute dans ce centre
Frankfurt, AllemagneAgaplesion Markus KrankenhausRecrute dans ce centre
Heidelberg, AllemagneBrustzentrum HeidelbergRecrute dans ce centre
Rostock, AllemagneUFK Klinikum Südstadt RostockRecrute dans ce centre
Wuppertal, AllemagneHelios Universitätsklinikum WuppertalRecrute dans ce centre
Schwaz, AutricheBrustzentrum SchwazRecrute dans ce centre
Vienna, AutricheSt. Josef Krankenhaus WienRecrute dans ce centre
Dubai, Émirats arabes unisMediclinic City Hospital DubaiRecrute dans ce centre

Au total, dans le monde, 25 des 26 centres listés au registre recrutent ; l'autre ne recrute pas actuellement.

Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 23 octobre 2024).

Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.

Voir aussi

Autres versions

Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.