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Clinical Trials in Italy / NCT06274515
Recruiting Phase 4

A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies

NCT06274515 · tracked via the Priya Life Science Italy tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 4
Started
2024-04-02
Last updated
2026-09-04

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Tumor Tissue and Blood Draw

Tumor Tissue and Blood Draw: Participants will have their blood drawn on the day a tissue sample is taken from a progressive tumor lesion.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
General Inclusion Criteria: * Willingness to undergo a procedure to obtain tumor tissue (e.g. biopsy) and blood draw * Diagnosis of HER2+, HR+ (for cohort R1) or triple negative breast cancer (for cohort T1) as per local assessment * Availability of an archival tumor tissue (most recent pre-treatment tumor tissue is preferred) * Unequivocally growing tumor lesion (progressive lesion) that is accessible for resection, excision or core needle biopsy * Discontinuation of prior anti-cancer treatment outlined below should not be longer than 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 local practice (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 while the 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 appearing lesion (as confirmed by routine tumor assessment) while treated for at least 4 weeks but less than 6 months on therapy Exclusion Criteria: * Any risks factors that increase the risk of complications associated with the procedure to obtain tumor tissue (e.g. bleeding disorders) * Any serious medical condition or abnormality in clinical laboratory tests that precludes 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 is in the bone * Discontinuation of treatment was due to a reason other than disease progression

Primary outcome measure(s)

  • Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) — At least 6 months
  • Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2) — At least 6 months
  • Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) — At least 6 months
  • Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3) — Less than 6 months
  • Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3) — Less than 6 months
  • Changes from baseline in ER protein levels measured at the time of disease progression/recurrence (Cohort H3) — Less than 6 months
  • Changes from baseline in genes related to CDK4/6 resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1) — At least 6 months
  • Changes from baseline in genes related to endocrine resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1) — At least 6 months
  • Changes from baseline in tumor immune microenvironment (PD-L1 and TILs, Cohort T1) — At least 6 months
  • Changes from baseline in immune phenotype (PD-L1 and TILs, Cohort T1) — At least 6 months

Trial sites (28)

FacilityCityRegionStatus
Institut Jules Bordet Anderlecht Belgium Recruiting
AZ KLINA Brasschaat Belgium Recruiting
CHU de Liège (Sart Tilman) Liège Belgium Recruiting
AZ Delta (Campus Rumbeke) Roeselare Belgium Recruiting
Aalborg Universitetshospital Aalborg Denmark Recruiting
Sjællands Universitetshospital, Næstved Næstved Denmark Recruiting
Helsinki University Central Hospital Helsinki Finland Recruiting
Tampere University Hospital Tampere Finland Recruiting
St. Elisabeth Krankenhaus Köln GmbH Cologne Germany Recruiting
KEM/Evang. Kliniken Essen Mitte gGmbH Essen Germany Recruiting
ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG Karlsruhe Germany Recruiting
Universitätsklinikum Mannheim Mannheim Germany Recruiting
Universitätsfrauenklinik Ulm Ulm Germany Recruiting
I.R.S.T Srl IRCCS Meldola Emilia-Romagna Recruiting
Azienda Ospedaliero - Universitaria di Modena Policlinico Modena Emilia-Romagna Recruiting
RCCS - Centro di Riferimento Aviano (PN) Friuli Venezia Giulia Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Lazio Recruiting
Ospedale San Raffaele S.r.l. - PPDS Milan Lombardy Recruiting
Irccs Istituto Nazionale Dei Tumori (Int) Milan Lombardy Recruiting
Irccs Istituto Europeo Di Oncologia (IEO) Milan Lombardy Recruiting
Oslo university hospital Radiumhospitalet Oslo Norway Withdrawn
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
HM Sanchinarro ? CIOCC Madrid Spain Recruiting
Hospital Universitario Virgen del Rocio Seville Spain Recruiting
Hospital Clínico Universitario de Valencia Valencia Spain Recruiting
Basingstoke and North Hampshire Hospital Basingstoke United Kingdom Recruiting
Imperial College Healthcare NHS Trust London United Kingdom Recruiting
Christie Hospital NHS Trust Manchester United Kingdom Recruiting

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A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis Active, not recruiting
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer Active, not recruiting

Other trials for the same condition

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A) Active, not recruiting
The OPBC-07/microNAC Study Active, not recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study Active, not recruiting
Music Therapy in Patients With Breast Cancer (IMPACT) Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06274515 on ClinicalTrials.gov ↗ ← All trials in Italy