Status:
RECRUITING
A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 rece...
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
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06274515
Start Date
April 2 2024
End Date
September 30 2026
Last Update
April 6 2026
Active Locations (28)
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1
Institut Jules Bordet
Anderlecht, Belgium, 1070
2
AZ KLINA
Brasschaat, Belgium, 2930
3
CHU de Liège (Sart Tilman)
Liège, Belgium, 4000
4
AZ Delta (Campus Rumbeke)
Roeselare, Belgium, 8800