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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Participants will have their blood drawn on the day a tissue sample is taken from a progressive tumor lesion.
Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2)
Time frame: At least 6 months
Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2)
Time frame: 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)
Time frame: At least 6 months
Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3)
Time frame: Less than 6 months
Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3)
Time frame: Less than 6 months
Changes from baseline in ER protein levels measured at the time of disease progression/recurrence (Cohort H3)
Time frame: Less than 6 months
Changes from baseline in genes related to CDK4/6 resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1)
Time frame: At least 6 months
Changes from baseline in genes related to endocrine resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1)
Time frame: At least 6 months
Changes from baseline in tumor immune microenvironment (PD-L1 and TILs, Cohort T1)
Time frame: At least 6 months
Changes from baseline in immune phenotype (PD-L1 and TILs, Cohort T1)
Reference Study ID Number: WO44977 https://forpatients.roche.com/ No attachments to email below.
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Anderlecht, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Aalborg, Denmark
RECRUITINGSjællands Universitetshospital, Næstved
Næstved, Denmark
RECRUITINGHelsinki University Central Hospital
Helsinki, Finland
RECRUITINGTampere University Hospital
Tampere, Finland
RECRUITINGSt. Elisabeth Krankenhaus Köln GmbH
Cologne, Germany
RECRUITINGKEM/Evang. Kliniken Essen Mitte gGmbH
Essen, Germany
RECRUITING...and 18 more locations
Time frame: At least 6 months