Investigating why some breast cancer therapies stop working

A Multi Cohort Translational Research Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies

This study is trying to understand why some breast cancer treatments stop working by looking at tumor and blood samples from people with different types of breast cancer.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hoffmann-La Roche (Industry-sponsored)
• Locations: 28 sites (Anderlecht and 27 other locations)
• Trial ID: NCT06274515 on ClinicalTrials.gov

What this trial studies

This study evaluates the mechanisms behind resistance to breast cancer therapies by analyzing tumor and blood samples from participants diagnosed with HER2 positive, hormone receptor positive, or triple negative breast cancer. Participants will undergo procedures to obtain tumor tissue and blood samples, allowing researchers to study the biological factors contributing to treatment resistance. The study aims to enhance understanding of how these cancers respond to therapies and identify potential new treatment strategies.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with HER2 positive, hormone receptor positive, or triple negative breast cancer who are willing to undergo biopsies and blood draws.

Not a fit: Patients who have not been diagnosed with breast cancer or those whose tumors are not accessible for biopsy may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved treatment options for patients with breast cancer who experience resistance to current therapies.

How similar studies have performed: Other studies investigating mechanisms of resistance in breast cancer have shown promise, indicating that this approach is both relevant and potentially impactful.

Eligibility criteria

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

Where this trial is running

Anderlecht and 27 other locations

• 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, Italy (Recruiting)
• Azienda Ospedaliero - Universitaria di Modena Policlinico — Modena, Emilia-Romagna, Italy (Recruiting)
• RCCS - Centro di Riferimento — Aviano (PN), Friuli Venezia Giulia, Italy (Recruiting)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Lazio, Italy (Recruiting)
• Ospedale San Raffaele S.r.l. - PPDS — Milan, Lombardy, Italy (Recruiting)
• Irccs Istituto Nazionale Dei Tumori (Int) — Milan, Lombardy, Italy (Recruiting)
• Irccs Istituto Europeo Di Oncologia (IEO) — Milan, Lombardy, Italy (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)

Study contacts

• Study coordinator: Reference Study ID Number: WO44977 https://forpatients.roche.com/

Conditions Breast Cancer