NCT06274515 A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies
| NCT ID | NCT06274515 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hoffmann-La Roche |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 320 participants in total. It began in 2024-04-02 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 receptor (HR) positive or triple negative breast cancer.
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
Contact & Investigator
Reference Study ID Number: WO44977 https://forpatients.roche.com/ No attachments to email below.
✉ global-roche-genentech-trials@gene.com📞 888-662-6728 (U.S. Only)
Clinical Trials
STUDY DIRECTOR
Hoffmann-La Roche
Frequently Asked Questions
Who can join the NCT06274515 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06274515 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06274515 currently recruiting?
Yes, NCT06274515 is actively recruiting participants. Contact the research team at global-roche-genentech-trials@gene.com for enrollment information.
Where is the NCT06274515 trial being conducted?
This trial is being conducted at Anderlecht, Belgium, Brasschaat, Belgium, Liège, Belgium, Roeselare, Belgium and 11 additional locations.
Who is sponsoring the NCT06274515 clinical trial?
NCT06274515 is sponsored by Hoffmann-La Roche. The principal investigator is Clinical Trials at Hoffmann-La Roche. The trial plans to enroll 320 participants.
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