This study is to explore the efficacy and safety of the first-line treatment of HER2 positive recurrent/metastatic breast cancer with Inetetamab combined with Pertuzumab or Pyrotinib combined with chemotherapy, hoping to have better clinical benefits and provide a new treatment mode for targeted treatment.
In terms of the anti-HER2 mechanism, the binding sites of Inetetamab and Trastuzumab are located in the extracellular domain IV, while the binding site of Pertuzumab is located in the conserved domain II, inhibiting HER2 phosphorylation and blocking downstream signaling pathways. The binding site of Pyrotinib is located in the intracellular tyrosinase active domain, which competes with ATP to block HER2 autophosphorylation and activation. Inetetamab combined with Pertuzumab "dual target" blocks HER2 dimer formation, while Inetetamab combined with Pyrotinib "dual target" inhibition can produce synergistic enhancement of anti-HER2 effect. This study is to explore the efficacy and safety of the first-line treatment of HER2 positive recurrent/metastatic breast cancer with Inetetamab combined with Pertuzumab or Pyrotinib combined with chemotherapy, hoping to have better clinical benefits and provide a new treatment mode for targeted treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Group A received Inetetamab+Pertuzumab+TPC, while Group B received Inetetamab+Pyrotinib+TPC.
Sun Yat sen Memorial Hospital of Sun Yat sen University Shenzhen Shantou Central Hospital
Shanwei, Guangdong, China
RECRUITINGOverall response rate (ORR)
An objective response was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR) determined by investigator using RECIST v1.1 on two consecutive occasions ≥4 weeks apart
Time frame: Tumor assessments every 6 weeks from Baseline until radiographical progressive disease (PD), death (whichever occurred first), up to the primary completion date (up to 2 years)
Progression-Free Survival (PFS)
PFS was defined as the time from first dose to first documented radiographical progressive disease (PD) using RECIST version 1.1, or death from any cause , whichever occurred first.
Time frame: Tumor assessments every 6 weeks from randomization to radiographical PD or death from any cause, whichever occurred first,up to the primary completion date (up to 2 years)
Clinical Benefit Rate (CBR)
Clinical benefit rate was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR) or stable disease(SD)\>6 months determined by investigator using RECIST v1.1 on two consecutive occasions ≥4 weeks apart.
Time frame: Tumor assessments every 6 weeks from Baseline until radiographical progressive disease (PD), death (whichever occurred first), up to the primary completion date (up to 2 years)
Number of Adverse Events using NCI CTCAE 5.0 [Safety and Tolerability]
Number of Adverse Events using NCI CTCAE 5.0
Time frame: From signing the informed consent to 30 days after last dose
Overall survival(OS)
Overall survival (OS) is defined as the time from the date of first dosing till death due to any cause.
Time frame: From date of the patient starts treatment of inetetamab combined with pyrotinib and vinorelbine and vinorelbine and death from any cause,assessed up to about 48 months.
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Duration of Respons(DoR)
The duration of respons refers to the time from the first assessment of CR or PR to the first assessment of PD or (for any reason) death, that is, the time during which the tumor continues to shrink after the patient receives a certain treatment plan.
Time frame: Tumor assessments every 6 weeks from Baseline until radiographical progressive disease (PD), death (whichever occurred first), up to the primary completion date (up to 2 years)