A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies
NCT ID: NCT06274515
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
320 participants
INTERVENTIONAL
2024-04-02
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mechanisms of Acquired Resistance
Participants with breast cancer who have a newly appearing or recurrent metastatic lesion while on anti-cancer therapy will be assigned to one of 3 cohorts.
Tumor Tissue and Blood Draw
Participants will have their blood drawn on the day a tissue sample is taken from a progressive tumor lesion.
Mechanisms of Primary Resistance
Participants with breast cancer who have a progressing tumor lesion while on anti-cancer therapy will be assigned to one of 2 cohorts.
Tumor Tissue and Blood Draw
Participants will have their blood drawn on the day a tissue sample is taken from a progressive tumor lesion.
Interventions
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Tumor Tissue and Blood Draw
Participants will have their blood drawn on the day a tissue sample is taken from a progressive tumor lesion.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Institut Jules Bordet
Anderlecht, , Belgium
CHU de Liège (Sart Tilman)
Liège, , Belgium
AZ Delta (Campus Rumbeke)
Roeselare, , Belgium
Aalborg Universitetshospital
Aalborg, , Denmark
Sjællands Universitetshospital, Næstved
Næstved, , Denmark
Helsinki University Central Hospital
Helsinki, , Finland
Tampere University Hospital
Tampere, , Finland
St. Elisabeth Krankenhaus Köln GmbH
Cologne, , Germany
KEM/Evang. Kliniken Essen Mitte gGmbH
Essen, , Germany
ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG
Karlsruhe, , Germany
Universitätsklinikum Mannheim
Mannheim, , Germany
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
Oslo university hospital Radiumhospitalet
Oslo, , Norway
Hospital Universitario 12 de Octubre
Madrid, , Spain
HM Sanchinarro ? CIOCC
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Basingstoke and North Hampshire Hospital
Basingstoke, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Christie Hospital NHS Trust
Manchester, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: WO44977 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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WO44977
Identifier Type: -
Identifier Source: org_study_id
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