This is a multi-center,randomized,phase 3 clinical trial. In the study, HER2-positive metastatic breast cancer patients with abnormal activation of PI3K/Akt/mTOR pathway after progression on trastuzumab are enrolled and randomized to receive the treatment of Inetetamab plus Rapamycin plus chemotherapy or Pyrotinib plus chemotherapy.The study aimed to access the efficacy and safety of Inetetamab combined with Rapamycin and chemotherapy in HER2-positive metastatic breast cancer patients with abnormal activation of PI3K/Akt/mTOR pathway.
Female, Aged > 18;
HER2-positive breast cancer are defined as immunohistochemical (IHC) testing as +++, or IHC++ with FISH testing of positive;
Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease.
Patients with HER2-positive breast cancer who have progressed during adjuvant trastuzumab treatment after surgery; or
Participated in other clinical trials within 4 weeks;
Have used mTOR inhibitors in the past;
Previous use of Pyrotinib in first-line treatment stage; previous use of lapatinib is allowed;
Accompanied by immunosuppressant or chronic corticosteroid medication, or more than 25% bone marrow radiotherapy within 4 weeks;
Parallel
Inetetamab
DrugInitial dose of 8mg/kg, completed in 90 minutes IV infusion, and then 6 mg/kg over 30-90 minutes IV infusion every 3 weeks.
Rapamycin
DrugOral 2mg, once a day.
Pyrotinib
DrugOral 400mg, once a day.
Chemotherapy
DrugChemotherapy drugs are not limited in this trial, please refer to their instructions for specific usage.
Progressive-free Survival (PFS)
Progressive-free Survival (PFS) is defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first.
Overall Response Rate (ORR)
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Overall Survival （OS）
Overall Survival （OS）is defined as the time from date of randomization to the date of death from any cause.
Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) is defined as the percentage of participants whose best overall response, according to RECIST1.1, is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks.
Safety(AEs and SAEs)
Adverse Events (AEs) and Serious Adverse Events (SAEs)
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