New hope for advanced breast cancer: SKB264 trial launches

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF; * Histologically and/or cytologically confirmed HR+/HER2- breast cancer based on pathology reports on recent biopsy specimens or other pathological samples; * Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage; * Patients with at least one measurable lesion per RECIST 1.1 criteria; those with only skin or bone lesions cannot be included; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; * Expected survival ≥ 12 weeks; * Adequate organ and bone marrow function; * Patients who are eligible for a chemotherapy regimen in the control group; * Female patients of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose; * Patients who voluntarily participate in the study and sign the ICF, and able to comply with the visit and related procedures stipulated in the plan. Exclusion Criteria: * Patients with a history of central nervous system (CNS) metastases or current CNS metastases； * Patients with other malignancies (except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix) within 3 years prior to the first dose; * Patients with any cardio cerebral Vascular disease or cardio cerebral vascular risk factors may affect investigational treatment; * Uncontrollable systemic diseases assessed by the investigator; * History of (noninfectious) interstitial lung disease (ILD)/noninfectious neumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or ILD/noninfectious pneumonitis at screening that cannot be excluded by imaging; * Clinically serious lung injuries caused by lung diseases; * Patients with active chronic Inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess or acute gastrointestinal bleeding; * Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1; * Active hepatitis B or hepatitis C; * Human immunodeficiency virus (HIV) antibody test positive or a history of acquired immunodeficiency syndrome (AIDS), known active syphilis infection; * Known allergy or hypersensitivity to SKB264, or the excipients of SKB264; * Prior TROP2 targeted therapy, prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy; * Patients who received major surgeries 4 weeks prior to the first dose of study treatment or planned to receive major surgeries during the study ; * Patients with concomitant infections requiring systemic antibiotic therapy within 2 week prior to the first dose of study treatment; * Patients who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study; * Pregnant or lactating women.