Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

List	Outcome	Time frame	Description
Primary	Efficacy of T-DXd as a first-line therapy - TFST	From date of enrollment until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled	Time to first subsequent anti-cancer therapy (TFST) is defined as the time from the date of first dose of the study treatment to the date of i) first subsequent anti-cancer therapy after disease progression or discontinuation of maintenance treatment (in patients who discontinued due to treatment-related toxicities), or ii) death from any cause, whichever occurs first
Primary	Health-related quality of life	From date of enrollment until the date of first documented progression, death, lost of follow-up, withdrawal of consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled.	Time to 10% physical functioning deterioration, based on the EORTC QLQ-C30 Physical Functioning scale. Values range from 0 to 100. Higher scores mean a better outcome.
Secondary	Adverse events (safety)	From date of enrollment until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled	Occurrence /severity of AEs, laboratory abnormalities, discontinuation rates, dose reductions/interruptions
Secondary	Percentage of any acute or delayed nausea and vomiting	From date of enrollment until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled	Percentage of any acute or delayed nausea and vomiting or breakthrough anti-emetic use, in patients receiving prophylactic anti-emetic agents (combination regimen of 3 medicinal products)
Secondary	Unplanned healthcare utilization	From date of enrollment until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled	Composite of ER visits, unplanned hospitalizations and non-programed visits
Secondary	Efficacy of T-DXd as a first-line therapy - PFS	From date of enrollment until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled	Progression-free survival, defined as the time from the date of first dose to the date of first clinical or radiological progression or death due to any cause, whichever occurs first, as assessed by the investigators' assessments and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Secondary	Efficacy of T-DXd as a first-line therapy - ORR	From date of enrollment until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled	Overall response rate (ORR), defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) as per local investigator's assessment and according to RECIST 1.1
Secondary	Efficacy of T-DXd as a first-line therapy - CBR	From date of enrollment until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled	Clinical benefit rate (CBR), defined as the proportion of patients with a best overall response of i) CR or PR or ii) SD or Non-CR/Non-PD lasting more than 24 weeks as per local investigator's assessment and according to RECIST 1.1
Secondary	Efficacy of T-DXd as a first-line therapy - TtR	From date of enrollment until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled	Time to response (TtR), defined as the time from the date of first dose to the first objective tumor response (tumor shrinkage of ≥30%) observed for patients who achieved a CR or PR
Secondary	Efficacy of T-DXd as a first-line therapy - DoR	From date of enrollment until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled	Duration of response (DoR), defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression, as per local investigator's assessment and according to RECIST 1.1., or death from any cause, whichever occurs first
Secondary	Patient reported outcomes for HrQoL - EORTC QLQ-C30	From date of enrollment until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled	1. Proportion of participants experiencing treatment-related symptoms as measured by selected scales from the EORTC QLQ-C30 - higher scores are associated with greater symptom severity. 2. Change from baseline in the global health status (GHS)/QoL scale - higher score means better overall health; 3. Time to 10% deterioration in the GHS/QoL scale - higher scores mean a better outcome
Secondary	Patient reported outcomes for HrQoL - EORTC QLQ-BR42	From date of enrollment until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled	Proportion of participants experiencing treatment-related symptoms as measured by selected scales from the EORTC QLQ-BR42 - higher scores are associated with greater symptom severity.
Secondary	Patient reported outcomes for HrQoL - CTCAE	Day 1 of each cycle until Cycle 9 (each cycle is 21 days)	Proportion of participants with maintained or improved treatment-related self-reported symptoms.
Secondary	Digital health tools - Adherence	From date of enrollment until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled	The study will also evaluate digital health adherence and utilization and identify factors predictive of digital health adherence. Usage patterns in digital health interventions vary (e.g., no use, partial use, early discontinuation, or full adherence). Adherence, defined by Donkin et al. as "the degree to which the user followed the program as designed," (Donkin et al. 2011) is generally linked to greater effectiveness, though alternative patterns may still meet treatment goals. Evaluating adherence and predictors of usage in cancer care is essential to improve design, tailoring, and engagement. In this study, patients will be group based on their digital adherence. This grouping will be performed by dividing the overall study population into tertiles according to their cumulative digital usage data. The groups will represent low, medium, and high digital adherence.
Secondary	Digital health tools - Patient typology and software solutions	From date of enrollment until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 60 months after the first patient enrolled	Comparative descriptive studies of outcome factors (e.g. patient reported outcomes, efficacy, adherence) in subgroups defined by individual patient characteristics, population, and software solution.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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