Patients diagnosed with advanced or metastatic cancer treated with Trastuzumab Deruxtecan in the context of a clinical trial/expanded access/ compassionate use or standard treatment, irrespective of histologic type.
Conditions
Brief summary
To identify the optimal ERBB2 mRNA cut-point predictive of DS-8201 response -Correlation of mRNA ERBB2 levels (as a continuous variable) in baseline FFPE tumor samples with overall response in the DS8201a-treated cohorts., Correlation of mRNA ERBB2 levels (as a continuous variable) in baseline FFPE tumor samples with overall response in the DS8201a-treated cohorts.
Detailed description
To evaluate the association of mRNA ERBB2 levels with progression- free survival and overall survival., To evaluate the association of the PAM50 intrinsic subtypes (Luminal A, Luminal B, HER2-enriched and Basal-like) with overall response rate, progression free survival (PFS) and overall survival (OS)., To evaluate the association of immune-related genes with overall response, progression free survival (PFS) and overall survival (OS)., To design a new gene expression signature predictive of DS8201a benefit, To evaluate the benefit of DS8201a across somatic mutations., To correlate early changes in ctDNA with DS8201a benefit., To identify acquired somatic mutations of resistance to DS8201a upon progression in plasma samples
Interventions
Sponsors
Solti Group
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify the optimal ERBB2 mRNA cut-point predictive of DS-8201 response -Correlation of mRNA ERBB2 levels (as a continuous variable) in baseline FFPE tumor samples with overall response in the DS8201a-treated cohorts., Correlation of mRNA ERBB2 levels (as a continuous variable) in baseline FFPE tumor samples with overall response in the DS8201a-treated cohorts. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the association of mRNA ERBB2 levels with progression- free survival and overall survival., To evaluate the association of the PAM50 intrinsic subtypes (Luminal A, Luminal B, HER2-enriched and Basal-like) with overall response rate, progression free survival (PFS) and overall survival (OS)., To evaluate the association of immune-related genes with overall response, progression free survival (PFS) and overall survival (OS)., To design a new gene expression signature predictive of DS8201a benefit, To evaluate the benefit of DS8201a across somatic mutations., To correlate early changes in ctDNA with DS8201a benefit., To identify acquired somatic mutations of resistance to DS8201a upon progression in plasma samples | — |
Countries
Spain
Outcome results
None listed