eligibility_summary
Adults (≥18) with unresectable/metastatic breast cancer. HER2+: prior anti‑HER2 regimen (metastatic or perioperative with relapse ≤6 mo), no anti‑HER2 ADC in metastatic, if adjuvant ADC, progressed >12 mo post‑therapy. HER2‑low (IHC 1+ or 2+/ISH–): ≥1 prior metastatic chemo or relapse ≤6 mo, HR+ tried or ineligible for endocrine therapy. SPP: consent required. Exclude: no T‑DXd start, ILD/pneumonitis, CrCl <30, AST/ALT >5×ULN, bilirubin >1.5×ULN (≥3× with Gilbert’s/liver mets).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Study: HER-TEMPO (NCT06386263), a non-interventional real-world Canadian cohort assessing patients with HER2+ or HER2-low metastatic breast cancer treated with trastuzumab deruxtecan (T-DXd/Enhertu). Drug/intervention and mechanism: T-DXd is an antibody-drug conjugate (ADC) comprising a humanized anti-HER2 IgG1 (trastuzumab) linked via a cleavable linker to a membrane-permeable topoisomerase I inhibitor payload (DXd). It binds HER2, is internalized, and releases DXd in lysosomes, causing topo I–mediated DNA damage and cell death, also inhibits HER2 signaling and can trigger Fc-mediated ADCC, bystander killing may occur. Cells/pathways targeted: HER2-expressing tumor cells (HER2-positive and HER2-low), HER2 receptor signaling (PI3K/AKT/MAPK) and DNA replication/repair via topoisomerase I inhibition.