Her2-positive, unresectable and/or metastatic breast cancer.
Conditions
Interventions
Product Code: DS-8201a
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: trastuzumab deruxtecan
Current Sponsor code: DS-8201A
Other descriptive name: Anti-HER2 antibody-drug
Sponsors
SOLTI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Women =18 years old who previously participated in Daichi Sankyo INC. sponsored Ds8201-A-U301 and Ds8201-A-U302, consented for the obtention of a fresh biopsy or for the donation of an archival metastatic biopsy and the future use of their tumor samples in breast cancer research may be enrolled. 2.The participant (or legally acceptable representative if applicable) provides written informed consent for the study. 3.Fulfill all inclusion and exclusion criteria of the Ds8201-A-U301 or U302 trials prior to inclusion. 4.The patient who have received at least one dose of the study treatments in Ds8201-A-U301 or U302 trials. 5.Availability of FFPE tumor block, collected prior to the inclusion in Ds8201-A-U301 or U302 trial, with an associated pathology report. The tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for PAM50 analysis prior to enrollment. Patients whose tumor tissue is not evaluable for central testing are not eligible. -Acceptable samples include core needle biopsies for deep tumor tissue or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions or biopsies from bone metastases. -Fine needle aspiration, brushing, cell pellet from pleural effusion and lavage samples are not acceptable. 6.Must be able to provide blood sample(s). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Not having participated to the Daichi Sankyo INC. sponsored Ds8201-A-U301, Ds8201-A-U302 trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -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.;Secondary Objective: -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;Primary end point(s): -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.;Timepoint(s) of evaluation of this end point: At the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -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;Timepoint(s) of evaluation of this end point: At the end of the study. | — |
Countries
Spain
Contacts
Public ContactArea Investigación Clínica
SOLTI
Outcome results
None listed