Breast Cancer
Conditions
Brief summary
The mean SUVmax in up to five ABY-025 avid lesions at the baseline investigation will be used to assess the primary objective of the study, i.e. to relate HER2-status on PET to the response according to RECIST v1.1 after 3-4 treatment cycles with T-DXd.
Detailed description
Changes (deltaSUVmax) in HER2-status in up to five target lesions according to [68Ga ]Ga-ABY-025 uptake prior to and after 3-4 cycles of treatment with T-DXd., Correlation between HER2-expressing total tumor volume (HER2-TTV; defined as proportion of ABY-025 avid lesions in relation to the total tumor volume (TTV, lesions ≥10 mm) defined on CT) at baseline and ORR, Progression Free and Overall Survival after treatment with T-DXd, Change in patient reported Health-Related Quality of Life (HR-QoL) as measured by the EQ-5D-5L questionnaire from baseline to the first treatment evaluation
Interventions
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean SUVmax in up to five ABY-025 avid lesions at the baseline investigation will be used to assess the primary objective of the study, i.e. to relate HER2-status on PET to the response according to RECIST v1.1 after 3-4 treatment cycles with T-DXd. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes (deltaSUVmax) in HER2-status in up to five target lesions according to [68Ga ]Ga-ABY-025 uptake prior to and after 3-4 cycles of treatment with T-DXd., Correlation between HER2-expressing total tumor volume (HER2-TTV; defined as proportion of ABY-025 avid lesions in relation to the total tumor volume (TTV, lesions ≥10 mm) defined on CT) at baseline and ORR, Progression Free and Overall Survival after treatment with T-DXd, Change in patient reported Health-Related Quality of Life (HR-QoL) as measured by the EQ-5D-5L questionnaire from baseline to the first treatment evaluation | — |
Countries
Sweden
Outcome results
None listed