eligibility_summary
Eligible: adults 18–75, female with pathologically confirmed HER2-low breast cancer, ECOG 0–1, adequate tumor sample, organ function, and ≥1 measurable lesion, able to consent and comply. Exclude: active/untreated CNS mets, uncontrolled effusions, major surgery <4 wks, recent multiple cancers, ILD/pneumonitis, uncontrolled illness or CV disease, HIV, active HBV/HCV, unresolved >Grade 1 prior toxicities.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase Ib/II trial in HER2‑low advanced/metastatic breast cancer evaluating SHR‑A1811 (a HER2‑targeted antibody‑drug conjugate) combined with: dalpiciclib (CDK4/6 inhibitor), fulvestrant (selective estrogen receptor degrader), bevacizumab (anti‑VEGF‑A mAb), the protocol also contemplates letrozole/anastrozole (aromatase inhibitors). Mechanisms/targets: SHR‑A1811 binds HER2 on tumor cells and, after internalization, delivers a cytotoxic payload to kill HER2‑expressing cells (potential bystander effect). Dalpiciclib blocks CDK4/6 to arrest G1‑S cell‑cycle progression. Fulvestrant degrades/antagonizes ER to shut down ER signaling, letrozole/anastrozole reduce estrogen synthesis. Bevacizumab inhibits VEGF‑A to suppress tumor angiogenesis. Targeted cells/pathways: HER2‑low tumor cells, ER pathway, CDK4/6 axis, VEGF‑driven endothelium.