A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies
Recruiting · NCT06274515 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Tumor Tissue and Blood Draw
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
28 locations listed.
- Aalborg Universitetshospital - Aalborg, Denmark
- Institut Jules Bordet - Anderlecht, Belgium
- Basingstoke and North Hampshire Hospital - Basingstoke, United Kingdom
- AZ KLINA - Brasschaat, Belgium
- St. Elisabeth Krankenhaus Köln GmbH - Cologne, Germany
- KEM/Evang. Kliniken Essen Mitte gGmbH - Essen, Germany
- Helsinki University Central Hospital - Helsinki, Finland
- ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG - Karlsruhe, Germany
- CHU de Liège (Sart Tilman) - Liège, Belgium
- Imperial College Healthcare NHS Trust - London, United Kingdom
- Hospital Universitario 12 de Octubre - Madrid, Spain
- HM Sanchinarro ? CIOCC - Madrid, Spain
- Christie Hospital NHS Trust - Manchester, United Kingdom
- Universitätsklinikum Mannheim - Mannheim, Germany
- Sjællands Universitetshospital, Næstved - Næstved, Denmark
- Oslo university hospital Radiumhospitalet - Oslo, Norway
- AZ Delta (Campus Rumbeke) - Roeselare, Belgium
- Hospital Universitario Virgen del Rocio - Seville, Spain
- Tampere University Hospital - Tampere, Finland
- Universitätsfrauenklinik Ulm - Ulm, Germany
- Hospital Clínico Universitario de Valencia - Valencia, Spain
- I.R.S.T Srl IRCCS - Meldola, Emilia-Romagna, Italy
- Azienda Ospedaliero - Universitaria di Modena Policlinico - Modena, Emilia-Romagna, Italy
- RCCS - Centro di Riferimento - Aviano (PN), Friuli Venezia Giulia, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Rome, Lazio, Italy
- Ospedale San Raffaele S.r.l. - PPDS - Milan, Lombardy, Italy
- Irccs Istituto Nazionale Dei Tumori (Int) - Milan, Lombardy, Italy
- Irccs Istituto Europeo Di Oncologia (IEO) - Milan, Lombardy, Italy