Trastuzumab Rezetecan (SHR-A1811) Versus Chemotherapy of Physician's Choice in Patients With HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis：A Randomized, Prospective, Open-Label Phase II Trial.
The goal of this clinical trial is to learn if Trastuzumab Rezetecan (SHR-A1811) is safe and tolerable for patients with HER2-Low unresectable/metastatic breast cancer complicated with visceral crisis. Participants will take Trastuzumab Rezetecan every three weeks, until disease progression or intolerable toxicity.
• Age: ≥18 years old and ≤75 years old;
• Pathologically confirmed HER2-Low unresectable or metastatic breast cancer;
• Visceral crisis is defined as severe organ dysfunction as assessed by signs, symptoms and laboratory studies, resulting from rapid progression of neoplastic disease and indicative of substantial visceral compromise that may serve as an indication for more aggressive therapeutic intervention, including：a）Liver visceral crisis: rapidly increasing bilirubin \>1.5 × ULN in the absence of Gilbert's syndrome or biliary tract obstruction；b）Lung visceral crisis: rapidly increasing dyspnoea at rest, not alleviated by drainage of pleural effusion；c）Other visceral crises: the evaluation is conducted by the clinician based on the definition of visceral crisis specified in the ABC7 guideline.
• Patients whom investigators deem to have indications for single-agent chemotherapy.
• Sufficient bone marrow function, defined as follows：a) Neutrophil count (ANC) ≥ 1,500/mm³ (1.5 × 10⁹/L)；b) Platelet count (PLT) ≥ 80 ×10\^9/L；c) Hemoglobin (Hb) ≥ 80 g/L；
• Patients who have received ≤ 1 line of chemotherapy in the advanced stage are permitted.
• Patients who have received endocrine therapy in the advanced stage are permitted.
• Previous treatment with CDK4/6 inhibitors is permitted.
• Previous or concurrent local treatment for symptom relief is permitted.
• For female subjects who are premenopausal or not surgically sterilized:
⁃ A serum pregnancy test must be performed within 7 days before the first dose of study drug, with a negative result. They must agree to either abstain from sexual activity or use a medically approved highly effective contraceptive method from the time of signing the informed consent form, throughout the study period, and for 1 year after the last dose of study drug.
• Patients must voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.