drugset / Trial / NCT04736589
Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2021-02-02
- Primary completion
- 2024-02-02
- Completion
- 2027-02-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inetetamab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Comparator | Pyrotinib | Small molecule | 400 mg | Oral |
| Subject | Sirolimus | Small molecule | 2 mg | Oral |