This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or docetaxel combined with trastuzumab and pertuzumab, respectively.
Subjects voluntarily enrolled in this study with good compliance
Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1
HER2 positive, recurrent or metastatic invasive breast cancer confirmed by histopathology or cell pathology
Defined hormone receptor (HR) status
It is known that there is spinal cord compression or active central nervous system metastasis;
Subjects with only skin and/or brain lesions as target lesions
Combined diseases and medical history
Have had or currently have other malignant tumors within the past 5 years of randomization
Parallel
TQB2102 for Injection
DrugTQB2102 is a next-generation HER2 Antibody-Drug Conjugate drug proposed for patients with HER2 positive Recurrent/Metastatic Breast Cancer.
Docetaxel combined + Trastuzumab +Pertuzumab
DrugPositive control.
Objective Response Rate
According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment.
Progression-Free Survival
It refers to the time between enrollment and the occurrence of objective disease progression or death caused by various reasons (whichever occurs first).
Overall Survival
It refers to the time between enrollment and death caused by various reasons.
Duration of Remission
The subjects with the best response determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as complete response (CR) or partial response (PR) are defined as the period from the first recorded tumor response to the first recorded disease progression or death from any cause, whichever occurs first.
The incidence of adverse events
During the period from the signing of the informed consent form by the subjects to 28 days after the last dose of medication/initiation of new anti-tumor treatment (based on the first occurrence), the incidence of adverse events was recorded according to the common adverse event (AE) evaluation criteria of the National Cancer Institute (NCI CTC AE 5.0 version).
The severity of adverse events
During the period from the signing of the informed consent form by the subjects to 28 days after the last dose of medication/initiation of new anti-tumor treatment (based on the first occurrence), the severity of adverse events was recorded according to the common AE evaluation criteria of the National Cancer Institute (NCI CTCAE 5.0 version).
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