TROPION Breast Respond in 1L TNBC
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDaiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
About this trial
There are no real-world data available on the effectiveness and safety of Dato-DXd in adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. This NIS will investigate the effectiveness of Dato-DXd, the demographic and clinical characteristics of the patients, and treatment patterns.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years at the time of screening
Negative for ER
Negative for progesterone receptor
Negative for HER2 with 0 or 1+ intensity on IHC or 2+ intensity on IHC and negative by in situ hybridization per the ASCO-CAP HER2 guideline
Disqualifiers
Pregnancy or breastfeeding
Patients who at time of data collection for this study are participating in an interventional study regardless of whether the study is double blind or open label. Patients that have participated in an interventional study which is completed but remain blinded are also excluded.
Trial population
Patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Dato-DXd
DrugThis is a non-interventional study and no drug was administered.
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Dato-DXd1 intervention
Trial outcomes
Primary outcomes
1
Real-world Time to Next Treatment (rwTTNT1)
rwTTNT1 is defined as the length of time from index date to the date the patient received an administration of their next systemic treatment regimen or to their date of death if the patient died before initiation of next systemic treatment.
Time frame
From index date to time up to approximately 50 monthsSecondary outcomes
1
Treatment Patterns of Neoadjuvant and Adjuvant Therapies
Time frame
From index date up to approximately 50 months2
Real-world Time to Next Treatment 2 (rwTTNT2)
rwTTNT2 is defined as the time from the start of Dato-DXd administration (1L) to the start of the second subsequent therapy (3L) or death.
Time frame
From index date up to approximately 50 months3
Real-world Time to Permanent Treatment Discontinuation of the Index Treatment (rwTTD1)
rwTTD1 is defined as the time between start of Dato-DXd administration and last administration or death.
Time frame
From index date up to approximately 50 months4
Reasons for rwTTNT1 and rwTNT2 Event
rwTTNT1 and rwTNT2 are defined as the number of participants categorized according to the reason for rwTTNT1 or rwTTNT2 event. Reasons may include disease progression, adverse events, death, or others.
Time frame
From index date up to approximately 50 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: