A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies

Last updated: April 15, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

4

Condition

Breast Cancer

Cancer

Treatment

Tumor Tissue and Blood Draw

Clinical Study ID

NCT06274515
WO44977
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone receptor (HR) positive or triple negative breast cancer.

Eligibility Criteria

Inclusion

General Inclusion Criteria:

  • Willingness to undergo a procedure to obtain tumor tissue (e.g. biopsy) and blooddraw

  • Diagnosis of HER2+, HR+ (for cohort R1) or triple negative breast cancer (for cohortT1) as per local assessment

  • Availability of an archival tumor tissue (most recent pre-treatment tumor tissue ispreferred)

  • Unequivocally growing tumor lesion (progressive lesion) that is accessible forresection, excision or core needle biopsy

  • Discontinuation of prior anti-cancer treatment outlined below should not be longerthan 4 weeks from participation in this study

Inclusion criteria for participants in the cohorts studying acquired resistance

  • Participant had undergone regular monitoring for disease progression as per localpractice (preferably every 3-6 months) while on most recent breast cancer therapy

  • Accessible tumor lesion that newly appeared or a lesion that started to regrow whilethe participant was at least 6 months on therapy

Inclusion criteria for participants in the cohort studying primary resistance

  • Accessible tumor lesion that continued to increase in size or a newly appearinglesion (as confirmed by routine tumor assessment) while treated for at least 4 weeksbut less than 6 months on therapy

Exclusion

Exclusion Criteria:

  • Any risks factors that increase the risk of complications associated with theprocedure to obtain tumor tissue (e.g. bleeding disorders)

  • Any serious medical condition or abnormality in clinical laboratory tests thatprecludes an individual's safe participation in and completion of the study

  • Participant has started treatment with subsequent anti-cancer therapy

  • Participants whose progressive tumor lesion that is targeted for biopsy/resection isin the bone

  • Discontinuation of treatment was due to a reason other than disease progression

Study Design

Total Participants: 320
Treatment Group(s): 1
Primary Treatment: Tumor Tissue and Blood Draw
Phase: 4
Study Start date:
April 02, 2024
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Institut Jules Bordet

    Anderlecht, 1070
    Belgium

    Active - Recruiting

  • CHU Sart-Tilman

    Liège, 4000
    Belgium

    Active - Recruiting

  • AZ Delta (Campus Rumbeke)

    Roeselare, 8800
    Belgium

    Active - Recruiting

  • Aalborg Universitetshospital

    Aalborg, 9000
    Denmark

    Active - Recruiting

  • Aalborg Universitetshospital; Onkologisk Afdeling

    Aalborg, 9000
    Denmark

    Active - Recruiting

  • Sjællands Universitetshospital, Næstved

    Naestved, 4700
    Denmark

    Active - Recruiting

  • Sjællands Universitetshospital, Næstved; Onkologisk Afdeling

    Naestved, 4700
    Denmark

    Active - Recruiting

  • Helsinki University Central Hospital

    Helsinki, 00029
    Finland

    Active - Recruiting

  • Helsinki University Central Hospital; Dept of Oncology

    Helsinki, 00029
    Finland

    Active - Recruiting

  • Tampere University Hospital

    Tampere, 33520
    Finland

    Active - Recruiting

  • Tampere University Hospital; Dept of Oncology

    Tampere, 33520
    Finland

    Active - Recruiting

  • KEM/Evang. Kliniken Essen Mitte gGmbH

    Essen, 45136
    Germany

    Active - Recruiting

  • KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie

    Essen, 45136
    Germany

    Active - Recruiting

  • ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG

    Karlsruhe, 76135
    Germany

    Active - Recruiting

  • ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik

    Karlsruhe, 76135
    Germany

    Active - Recruiting

  • St. Elisabeth Krankenhaus Köln GmbH

    Koeln, 50935
    Germany

    Active - Recruiting

  • St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

    Koeln, 50935
    Germany

    Active - Recruiting

  • Universitätsklinikum Mannheim

    Mannheim, 68167
    Germany

    Active - Recruiting

  • Universitätsklinikum Mannheim; Frauenklinik

    Mannheim, 68167
    Germany

    Active - Recruiting

  • I.R.S.T Srl IRCCS

    Meldola, Emilia-Romagna 47014
    Italy

    Active - Recruiting

  • I.R.S.T Srl IRCCS; Oncologia Medica

    Meldola, Emilia-Romagna 47014
    Italy

    Active - Recruiting

  • Azienda Ospedaliero - Universitaria di Modena Policlinico

    Modena, Emilia-Romagna 41110
    Italy

    Active - Recruiting

  • RCCS - Centro di Riferimento

    Aviano (PN), Friuli-Venezia Giulia 33081
    Italy

    Active - Recruiting

  • RCCS - Centro di Riferimento; Oncologia Medica B

    Aviano (PN), Friuli-Venezia Giulia 33081
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Lazio 00168
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio 00168
    Italy

    Site Not Available

  • Irccs Istituto Europeo Di Oncologia (IEO)

    Milano, Lombardia 20141
    Italy

    Active - Recruiting

  • Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche

    Milano, Lombardia 20141
    Italy

    Active - Recruiting

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milano, Lombardia 20133
    Italy

    Active - Recruiting

  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

    Milano, Lombardia 20133
    Italy

    Active - Recruiting

  • Ospedale San Raffaele S.r.l. - PPDS

    Milano, Lombardia 20132
    Italy

    Active - Recruiting

  • Oslo universitetssykehus HF, Ullevål, Kreftsenteret

    Oslo, 0450
    Norway

    Active - Recruiting

  • Oslo university hospital Radiumhospitalet

    Oslo, 0424
    Norway

    Active - Recruiting

  • HM Sanchinarro ? CIOCC

    Madrid, 28050
    Spain

    Active - Recruiting

  • HM Sanchinarro ? CIOCC; Servicio de Oncologia

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Basingstoke and North Hampshire Hospital

    Basingstoke, RG24 9NA
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare NHS Trust

    London, W6 8RF
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare NHS Trust;Medical Oncology

    London, W6 8RF
    United Kingdom

    Active - Recruiting

  • Christie Hospital NHS Trust

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

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