Breast Cancer
Conditions
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.
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3) | Less than 6 months |
| Changes from baseline in ER protein levels measured at the time of disease progression/recurrence (Cohort H3) | Less than 6 months |
| Changes from baseline in genes related to CDK4/6 resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1) | At least 6 months |
| Changes from baseline in genes related to endocrine resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1) | At least 6 months |
| Changes from baseline in tumor immune microenvironment (PD-L1 and TILs, Cohort T1) | At least 6 months |
| Changes from baseline in immune phenotype (PD-L1 and TILs, Cohort T1) | At least 6 months |
| Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) | At least 6 months |
| Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2) | At least 6 months |
| Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) | At least 6 months |
| Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3) | Less than 6 months |
Countries
Belgium, Denmark, Finland, Germany, Italy, Norway, Spain, United Kingdom
Contacts
CONTACTReference Study ID Number: WO44977 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed