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.
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 after progression on trastuzumab. The primary end point is Progressive-free Survival (PFS). The secondary end points are Overall Response Rate (ORR),Overall Survival (OS),Clinical Benefit Rate (CBR) and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Initial dose of 8mg/kg, completed in 90 minutes IV infusion, and then 6 mg/kg over 30-90 minutes IV infusion every 3 weeks.
Oral 2mg, once a day.
Oral 400mg, once a day.
Chemotherapy drugs are not limited in this trial, please refer to their instructions for specific usage.
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
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.
Time frame: Estimated 24 months
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.
Time frame: Estimated 24 months
Overall Survival (OS)
Overall Survival (OS)is defined as the time from date of randomization to the date of death from any cause.
Time frame: Estimated 48 months
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.
Time frame: Estimated 24 months
Safety(AEs and SAEs)
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From consent through 28 days following treatment completion
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