The study is being conducted to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and immunogenicity of SHR-A1811 combined with capecitabine in treatment of unresectable or metastatic breast cancer with low HER2 expression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
116
SHR-A1811 for injection; Capecitabine tablets
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijng, China
RECRUITINGDLT(Phase I (dose exploration phase) ) [ Time Frame: 21 days after the first administration of each subject ]
Time frame: 21 days after the first administration of each subject ]
Incidence of AEs(Phase I (dose exploration phase) )
Time frame: from Day1 to 40 days after last dose
Incidence of SAEs(Phase I (dose exploration phase) )
Time frame: from Day1 to 40 days after last dose
Objective response rate(Phase II (efficacy expansion phase))
Time frame: One year after the last subject was enrolled in the group
Duration of response(DoR )
Time frame: One year after the last subject was enrolled in the group
Progression Free Survival(PFS)
Time frame: One year after the last subject was enrolled in the group
Objective response rate(Phase I (dose exploration phase))
Time frame: One year after the last subject was enrolled in the group
Incidence of AEs(Phase II (efficacy expansion phase))
Time frame: from Day1 to 40 days after last dose
Incidence of SAEs(Phase II (efficacy expansion phase))
Time frame: from Day1 to 40 days after last dose
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Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College
Nanning, Guangxi, China
Shantou Central Hospital
Shantou, Guangzhou, China
NOT_YET_RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
RECRUITINGThe First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGThe First Hospital of China Medical University
Shenyang, Liaoning, China
NOT_YET_RECRUITINGShandong Cancer Hospital&Institute
Jinan, Shandong, China
NOT_YET_RECRUITINGWenzhou People's Hospital
Wenzhou, Zhejiang, China
NOT_YET_RECRUITING