TQB2930 is a HER2 bispecific antibody drug. This study aims to evaluate the efficacy and safety of TQB2930 combined with investigator's choice of chemotherapy versus trastuzumab combined with investigator's choice of chemotherapy in subjects with HER2-positive advanced breast cancer who have received at least two prior lines of anti-HER2 therapy in the advanced station.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
416
TQB2930 injection is a HER2 bispecific antibody drug； Chemotherapy: Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.
Trastuzumab is a HER2-specific targeted drug； Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.
Progression-free survival (PFS)
Independent Imaging Review Committee (IRC)-assessed PFS
Time frame: Baseline up to IRC-assessed Disease Progression(PD), approximately 1 years
PFS assessed by Investigator
PFS assessed by Investigator
Time frame: Baseline up to Investigator-Assessed investigator, approximately 1 years
Overall survival (OS)
From randomization to the time of death from any cause.
Time frame: From date of the first dose until the date of death from any cause, up to approximately 2 years
Duration of Response (DOR)
Subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 criteria.
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, up to approximately 2 years
Proportion of subjects achieving partial response (PR)
Subjects with partial response (PR) per RECIST 1.1 criteria.
Time frame: From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years
Objective Response Rate (ORR)
Percentage of subjects achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria.
Time frame: From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
NOT_YET_RECRUITINGAnhui Provincial Hospital( The First Affiliated Hospital of USTC)
Hefei, Anhui, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGThe Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGChong Qing University Cancer Hospital
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGFuzhou First Generel Hospital Affiliated with Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGThe First Hospital of Lanzhou University
Lanzhou, Gansu, China
NOT_YET_RECRUITINGGansu Cancer Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGSun Yat - sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGPeking University Shenzhen Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITING...and 65 more locations
Clinical Benefit Rate (CBR)
Proportion of subjects with best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD) lasting ≥24 weeks per RECIST 1.1 criteria.
Time frame: From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first) , up to approximately 1 years
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: From baseline until 90 days after the last dose or initiation of new antitumor therapy, whichever occurs first
Plasma concentration of TQB2930
Serum concentrations of TQB2930 in subjects after administration in the treatment group.
Time frame: Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, and Cycle 12 Day 1; and within 30 minutes after dosing on Cycle 4 Day 1 and Cycle 7 Day 1, each cycle is 21 days
Anti-Drug Antibody (ADA) Positivity Rate
Anti-drug antibody (ADA) positivity in post-dose blood samples from subjects in the treatment group.
Time frame: Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, and Cycle 12 Day 1; and within 90 days after the last dose, each cycle is 21 days
Anti-Drug Antibody (ADA) Positivity Rate
Neutralizing antibody (NAb) testing performed when anti-drug antibodies (ADAs) were detected in post-dose blood samples from the treatment group.
Time frame: Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1 , and Cycle 12 Day 1; and within 90 days after the last dose, each cycle is 21 days