Study identifier:D9673R00036
ClinicalTrials.gov identifier:NCT06231693
EudraCT identifier:N/A
CTIS identifier:N/A
Trastuzumab-deruxtecan in patients with triple-negative metastatic HER2-Low breast cancer: real-world experience in Brazil
Breast Cancer
N/A
No
Trastuzumab deruxtecan
All
2
Observational
18 Years - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
Hospital Israelita Albert Einstein
A national, multicenter, retrospective, observational study (Real-World Evidence-RWE) aimed to assess the efficacy of Trastuzumab-deruxtecan (T-DXd) in patients with triple-negative (RE<10%) metastatic HER2-Low breast cancer.
Data from study DESTINY-04 have established T-DXd as the standard second-line treatment for HER2-Low breast tumors. In that study, about 90% of the population had estrogen-positive receptor (ER+) tumors, under-representing negative ER population. The investigators propose to assess T-DXd efficacy in HER2-Low/ER ≤10% patients in Brazilian population by means of a RWE analysis. Endpoints will be assessment of time to the next treatment, objective response rate, and real-world progression-free survival and real-world overall survival.
Location
Location
São Paulo, São Paulo, Brazil
Location
Porto Alegre, Rio Grande Do Sul, Brazil
Arms | Assigned Interventions |
---|---|
Trastuzumab-deruxtecan | - |
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