NCT07867470Not yet recruiting
TROPION Breast Respond in 1L TNBC
A Prospective Non-Interventional Study (NIS) of Dato-DXd (Datopotamab Deruxtecan) in Adult Patients With Unresectable or Metastatic Triple-negative Breast Cancer in the First Line Setting.
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 5 Oct 2026
- Start date
- 1 Mar 2027
- Primary completion date
- 1 Jan 2031
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07867470
What you commit to
- Study type: Observational
- Planned participants: 400
- From 1 Mar 2027 to the primary completion date, 1 Jan 2031
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- Age ≥18 years at the time of screening
- Histologically or cytologically documented locally recurrent inoperable or metastatic TNBC defined as:
- 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
- Patients must not be a candidate for PD-1/PD-L1 inhibitor therapy, defined as either the tumor was PD-L1 negative (Combine Positive Score (CPS \< 10), or it was PD-L1 positive (CPS ≥ 10 ) and: have relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer or patient was not eligible for IO therapy due to comorbidities precluding PD-1/PD-L1 inhibitor therapy
- Patients had not received prior chemotherapy or other systemic anti-cancer therapy for unresectable or metastatic breast cancer
- Decision to newly initiate therapy Dato-DXd according to the physician's choice per SmPC. If the patient received just one dose of Dato-DXd already, the patient can still be included retrospectively
- Written and signed Informed Consent (ICF) to participate in the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.