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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
642
TQB2102 is a next-generation HER2 Antibody-Drug Conjugate drug proposed for patients with HER2 positive Recurrent/Metastatic Breast Cancer.
Positive control.
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGAnhui Provincial Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGBeijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGGansu Provincial Cancer Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGObjective 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.
Time frame: Up to approximately 30 months
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).
Time frame: Up to approximately 30 months
Overall Survival
It refers to the time between enrollment and death caused by various reasons.
Time frame: Up to approximately 30 months
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.
Time frame: Up to approximately 30 months
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).
Time frame: Up to approximately 52 months
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).
Time frame: Up to approximately 52 months
Blood concentrations of the Antibody-Drug Conjugate (ADC) drug TQB2102
To evaluate the pharmacokinetic (PK) profile of TQB2102 for injection in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Time frame: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8and 15 minutes after the end of infusion for Cycle 2, Cycle 4, (21 days as a treatment cycle)
The incidence of drug-resistant antibodies (ADA) and neutralizing antibodies (NAb)
The incidence of drug-resistant antibodies (ADA) and neutralizing antibodies (NAb)
Time frame: within 60 minutes prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8, Cycle16,and before administration and 28 days (± 7 days), (21 days as a treatment cycle)
Total antibodies
To evaluate the pharmacokinetic (PK) profile of TQB2102 for injection in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Time frame: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8and 15 minutes after the end of infusion for Cycle 2, Cycle 4, (21 days as a treatment cycle)
The small molecule toxin TQ22723
To evaluate the pharmacokinetic (PK) profile of TQB2102 for injection in subjects with HER2 low-expressing recurrent/metastatic breast cancer.
Time frame: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2,,Cycle 4, Cycle 8and 15 minutes after the end of infusion for Cycle 2, Cycle 4, (21 days as a treatment cycle)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGShantou Central Hospital
Shantou, Guangdong, China
NOT_YET_RECRUITINGAffiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGHuaihe Hospital of Henan University
Kaifeng, Henan, China
NOT_YET_RECRUITINGPuyang Oilfield General Hospital
Puyang, Henan, China
NOT_YET_RECRUITINGThe Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China
NOT_YET_RECRUITING...and 15 more locations