This study aims to evaluate the efficacy and safety of TQB2102 for injection in HER2 negative recurrent/metastatic breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
TQB2102 for injection is a HER2 dual-antibody-drug conjugate (ADC).
Bozhou People's Hospital
Bozhou, Anhui, China
NOT_YET_RECRUITINGObjective 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.
Time frame: Up to 24 months after study start.
Progression-free survival
From randomization to the time of disease progression or death, whichever occurs first.
Time frame: Up to 36 months after study start
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.
Time frame: Up to 24 months after study start
Disease control rate
Percentage of subjects with CR, PR, or stable disease(SD) at 6 weeks or more as determined by RECIST 1.1.
Time frame: Up to 24 months after study start
Clinical benefit rate
The percentage of subjects achieving CR, PR or SD as assessed by the investigator based on the RECIST 1.1.
Time frame: Up to 24 months after study start
Overall survival
From randomization to the time of death from any cause.
Time frame: Up to 48 months after study start
Incidence of adverse events
All adverse medical events (e.g. adverse events, serious adverse event and abnormal laboratory values) that occurred after the subject received the investigational drug.
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Chuzhou First People's Hospital
Chuzhou, Anhui, China
Anhui Provincial Public Health Clinical Center
Hefei, Anhui, China
NOT_YET_RECRUITINGMa'anshan People's Hospital
Ma’anshan, Anhui, China
NOT_YET_RECRUITINGWuhu Hospital Affiliated to East China Normal University
Wuhu, Anhui, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGThe Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China
NOT_YET_RECRUITINGThe First People's Hospital of Zhengzhou
Zhengzhou, Henan, China
RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, Hubei, China
NOT_YET_RECRUITINGThe First People's Hospital of Changde City
Changde, Hunan, China
NOT_YET_RECRUITING...and 6 more locations
Time frame: Up to 36 months after study start
Anti-drug antibody (ADA)
Incidence of ADA
Time frame: 1 hour Before infusion on Cycle 1 Day1, Cycle 2 Day1, Cycle 4 Day1, Cycle 7 Day1, Cycle 12 Day1, and 30 days after the end of the last infusion. Each cycle is 21 days
HER2
Correlation analysis between HER2 expression level and TQB2102 treatment response
Time frame: Up to 24 months after study start
circulating tumor DNA (ctDNA)
Exploring the genetic variation and dynamic changes of ctDNA, including ctDNA clearance。
Time frame: Up to 24 months after study start