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Tumor Tissue and Blood Draw / Breast Cancer · Phase 4 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 4 mechanistic study registered at ClinicalTrials.gov investigating biomarker changes associated with resistance to HER2-targeted, endocrine, CDK4/6, and immune therapies in breast cancer. The study is currently recruiting and has not yet reported results; it aims to characterize resistance mechanisms in tissue and blood samples across HER2-positive, HR-positive, and triple-negative populations.
Phase 4, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Breast Cancer; age from 18 Years. Intervention: Mechanisms of Acquired Resistance; Mechanisms of Primary Resistance. n = 320. 28 sites across 8 countries.
This is a Phase 4 mechanistic study registered at ClinicalTrials.gov investigating biomarker changes associated with resistance to HER2-targeted, endocrine, CDK4/6, and immune therapies in breast cancer. The study is currently recruiting and has not yet reported results; it aims to characterize resistance mechanisms in tissue and blood samples across HER2-positive, HR-positive, and triple-negative populations.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This study does not yet provide clinical evidence. Once results are published, the characterization of biomarker changes at the time of therapeutic resistance may inform future strategies for predicting or overcoming resistance in breast cancer treatment.
This is a recruiting Phase 4 mechanistic study with no results posted; it aims to characterize resistance mechanisms via tissue and blood biomarkers but has not yet generated outcome data.
As stated by the source record.
Quoted from the source exactly as published.
This study does not yet provide clinical evidence. Once results are published, the characterization of biomarker changes at the time of therapeutic resistance may inform future strategies for predicting or overcoming resistance in breast cancer treatment.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06274515). This is a study registration, not published results. Lead sponsor: Hoffmann-La Roche. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 320 participants (ESTIMATED). Conditions: Breast Cancer. Interventions: PROCEDURE: Tumor Tissue and Blood Draw. Primary outcome measures: 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; 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. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.