RecruitingPhase 4NCT06274515
A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies
A Multi Cohort Translational Research Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies
Sponsor
Hoffmann-La Roche
Enrollment
320 participants
Start Date
Apr 2, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria8
- 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
- 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 Criteria5
- 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
Interventions
PROCEDURETumor Tissue and Blood Draw
Participants will have their blood drawn on the day a tissue sample is taken from a progressive tumor lesion.
Locations(28)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06274515
Related Trials
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors
NCT0661828763 locations
Early Phase Study of KESONOTIDE™in Participants With Solid Tumours
NCT069260753 locations
Cardiac Outcomes With Near-Complete Estrogen Deprivation
NCT053096553 locations
Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors
NCT041190243 locations
EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients
NCT074780161 location