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Disitamab vedotin

Immunoconjugates

Immunologic Factors

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.

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.

Disitamab Vedotin+Anlotinib

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 of Disitamab Vedotin and Anlotinib in Patients With HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer

Combination of Disitamab Vedotin and Anlotinib in the Treatment of HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer: A Single-Arm, Multicenter, Phase II Clinical Study

The percentage of cases that have achieved complete or partial remission after drug treatment compared to the total evaluable cases.

All adverse events (AEs) in this study will be encoded using MedDRA and classified according to the NCICTCAEv5.0 grading system.

Defined as the time from the beginning of the patient's treatment to death from any cause.

The proportion of patients who achieve complete remission (CR), partial remission (PR), or disease stability (SD) during or after treatment

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Disitamab Vedotin and Anlotinib in Patients With HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer	NCT06000033	Breast Cancer	Disitamab Vedot...	18 Years -	Qilu Hospital of Shandong University
Study of Disitamab Vedotin and Anlotinib in Patients With HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer	NCT06000033	Breast Cancer	Disitamab Vedot...	18 Years -	Qilu Hospital of Shandong University

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