This study aims to evaluate the efficacy and safety of TQB2102 for injection in HER2 negative recurrent/metastatic breast cancer.
The participants voluntarily participate in the study and sign an informed consent form.
Age: 18-75 years old; Eastern Cooperative Oncology Group (ECOG) score: ≤1 point; Expected survival period exceeds 3 months.
Breast cancer patients diagnosed as HER2 negative by pathology, with evidence of local recurrence or distant metastasis are not suitable for surgery or radiation therapy aimed at healing.
Sufficient tumor tissue samples must be available for HER2 evaluation by pathologists at the main research center.
Have experienced or currently suffer from other malignant tumors within 5 years prior to the first medication use;
Uncontrollable toxic reactions above CTCAE level 1 caused by any previous treatment;
Received significant surgical treatment or significant traumatic injury within 28 days prior to the first medication use;
Long term unhealed wounds or fractures;
Single group
TQB2102 for injection
DrugTQB2102 for injection is a HER2 dual-antibody-drug conjugate (ADC).
Objective response rate
The percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator based on the RECIST 1.1.
Progression-free survival
From randomization to the time of disease progression or death, whichever occurs first.
Duration of disease remission
For subjects whose best response is CR or PR , it is defined as from the date when tumor response is first recorded to the date when disease progression is first recorded or the date of death from any cause, whichever occurs first.
Disease control rate
Percentage of subjects with CR, PR, or stable disease(SD) at 6 weeks or more as determined by RECIST 1.1.
Clinical benefit rate
The percentage of subjects achieving CR, PR or SD as assessed by the investigator based on the RECIST 1.1.
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