Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer
To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.
• Female patients aged 18-70 years (including 18 years and 70 years)
• Expected survival ≥12 weeks
• ECOG 0-1
• Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable
• At least one measurable lesion according to the RECIST 1.1
• No history of antibody-drug conjugate use
• Up to one previous chemotherapy for advanced disease
• Available hormone receptor status. Hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease
• HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test
• Adequate organ function