A proof of concept study to evaluate treatments´efficacy by monitoring Minimal Residual Disease using ctDNA in HR-positive/HER2-negative early breast cancer population. -The MIRADOR study-

Early-stage, Hormone Receptor (HR)-positive / Human Epidermal Growth Factor Receptor 2 (HER2)-negative, breast cancer (BC)

Treatment phase: Proportion of patients with at least a 90% decrease or clearance in baseline ctDNA at three months after initiation of study treatment

Surveillance phase: Total ctDNA detection and breakdown by incidence at first ctDNA test versus incidence at subsequent ctDNA tests., Treatment phase: Proportion of patients with at least a 90% decrease in baseline ctDNA at six, nine, and 12 months after initiation of study treatment, Treatment phase: Proportion of patients with at least a 90% decrease in baseline ctDNA at three months maintained at six months and 12 months after initiation of study treatment., Treatment phase: Proportion of patients with 50% and 70% decrease in baseline ctDNA at three, six, nine, and 12 months after initiation of study treatment., Treatment phase: Time to rising ctDNA defined as time to first ctDNA increase compared to baseline, Treatment phase: Duration of at least a 90% decrease in baseline ctDNA after initiation of study treatment., Treatment phase: Best percentage of ctDNA decrease relative to baseline at six, nine, and 12 months after initiation of study treatment, Treatment phase: Safety and toxicity profile according to the NCI-CTCAE v.5.0., Evaluation of the primary and secondary outcomes based on the actual Study treatment received, including analyses within Arm A patients after switching treatment at month 3 and in the overall Study population. • Association of clinical outcomes, safety and/or tolerability profile with mutation profiling, copy number variability, gene expression, multiplex assays, proteomic analyses, digital pathology, immunohistochemistry, taxonomic o

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