Metastatic Breast Cancer
Conditions
Brief summary
Part 1: AEs, SAEs, DLTs, laboratory findings, Part 2: AEs, SAEs, laboratory findings
Detailed description
Part 2: ORR defined as the proportion of patients who have a confirmed CR or PR, as determined by the investigator at local site per RECIST 1.1, Part 2: PFS defined as time from the date of first dose until the date of progression as determined by the investigator at local site per RECIST 1.1, or death due to any cause, Part 2: DoR defined as time from the date of first documented response (which is subsequently confirmed) until the date of documented progression or death in the absence of disease progression, Part 2: OS defined as time from the date of first dose until the date of death by any cause, Serum concentration of T-DXd, total anti-HER2 antibody and MAAA- 1181a, Serum concentration of durvalumab, Immunogenicity of T-DXd and durvalumab
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: AEs, SAEs, DLTs, laboratory findings, Part 2: AEs, SAEs, laboratory findings | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 2: ORR defined as the proportion of patients who have a confirmed CR or PR, as determined by the investigator at local site per RECIST 1.1, Part 2: PFS defined as time from the date of first dose until the date of progression as determined by the investigator at local site per RECIST 1.1, or death due to any cause, Part 2: DoR defined as time from the date of first documented response (which is subsequently confirmed) until the date of documented progression or death in the absence of disease progression, Part 2: OS defined as time from the date of first dose until the date of death by any cause, Serum concentration of T-DXd, total anti-HER2 antibody and MAAA- 1181a, Serum concentration of durvalumab, Immunogenicity of T-DXd and durvalumab | — |
Countries
Belgium