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Trastuzumab deruxtecan / Metastatic Breast Cancer / HER2 Low Expressing Breast Cancer · Observational Study
ClinicalTrials.gov · August 19, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a recruiting observational registry study designed to collect real-world evidence on time to next treatment in patients with unresectable or metastatic HER2-low or HER2-(ultra)low breast cancer receiving trastuzumab deruxtecan. No results are currently posted in this registry record, and outcomes remain unknown.
Observational. Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-(Ultra)Low Expressing Breast Cancer; age from 18 Years. Intervention: Study Group 1; Study Group 2. n = 2,295. 216 sites across 10 countries.
This is a recruiting observational registry study designed to collect real-world evidence on time to next treatment in patients with unresectable or metastatic HER2-low or HER2-(ultra)low breast cancer receiving trastuzumab deruxtecan. No results are currently posted in this registry record, and outcomes remain unknown.
No efficacy, safety, or outcome data are available in this record.
The source did not state who this applies to in practice.
This is a registry record for an ongoing observational study with no results reported; it describes a planned real-world evidence collection in HER2-low breast cancer but cannot yet support clinical conclusions.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05945732). This is a study registration, not published results. Lead sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 2295 participants (ESTIMATED). Conditions: Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-(Ultra)Low Expressing Breast Cancer. Interventions: DRUG: Trastuzumab deruxtecan. Primary outcome measures: Real World Time to Next Treatment (rwTTNT1) in Participants With Unresectable and/or Metastatic Breast Cancer , Baseline up to approximately 37 months. Brief summary: Trastuzumab deruxtecan (T-DXd) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Based on the extended therapeutic indication of Trastuzumab deruxtecan (Enhertu®), a new patient population will be enrolled, comprising adult patients with unresectable or metastatic HR-positive, HER2-low, or HER2-(ultra)low breast cancer who have received at least one endocrine therapy in the metastatic setting and are not considered suitable for endocrine therapy as the next line of treatment.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.