Disitamab Vedotin (RC48) contains the novel humanized anti-HER2 antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable linker , which is the first ADC drug that was independently developed by Rongchang Biology .The aim of this study is to evaluate the efficacy and safety of RC48 in Combination with Anlotinib for the treatment of metastatic breast cancer with HR negativity and HER2 low expression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Disitamab Vedotin:2 mg/kg,ivgtt,d1-14/28day/cycle Anlotinib: 12mg once daily (taken before meals) orally, continuously for 2 weeks followed by a 1-week break. Each cycle consists of 21 days.
Objective response rate (ORR)
The percentage of cases that have achieved complete or partial remission after drug treatment compared to the total evaluable cases.
Time frame: 1year
Progression-Free Survival (PFS)
All adverse events (AEs) in this study will be encoded using MedDRA and classified according to the NCICTCAEv5.0 grading system.
Time frame: 2years
Overall Survival (OS)
Defined as the time from the beginning of the patient's treatment to death from any cause.
Time frame: 2years
Disease Control Rate (DCR)
The proportion of patients who achieve complete remission (CR), partial remission (PR), or disease stability (SD) during or after treatment
Time frame: 1year
Duration of Response (DOR)
Defined as the date from which tumor remission was first recorded (evaluated according to the RECIST 1.1 standard) to the date when disease progression was first recorded (evaluated according to the RECIST 1.1 standard) or the date of death from any cause.
Time frame: 1year
AEs
All adverse events (AEs) in this study will be encoded using MedDRA and classified according to the NCICTCAEv5.0 grading system.
Time frame: 2years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.