Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04736589
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-02-03
First Post:
2021-01-31
Brief Title:
Inetetamab Plus Rapamycin and Chemotherapy for HER2 Metastatic Breast Cancer With Abnormal Activation of PAM Pathway
Sponsor:
Peking Union Medical College
Organization:
Peking Union Medical College
Study Overview
Official Title:
Efficacy and Safety of Inetetamab Combined With Rapamycin and Chemotherapy for HER2-positive Metastatic Breast Cancer Patients With Abnormal Activation of PI3KAktmTOR Pathway After Progression on Trastuzumab
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-centerrandomizedphase 3 clinical trial In the study HER2-positive metastatic breast cancer patients with abnormal activation of PI3KAktmTOR pathway after progression on trastuzumab are enrolled and randomized to receive the treatment of Inetetamab plus Rapamycin plus chemotherapy or Pyrotinib plus chemotherapyThe 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 PI3KAktmTOR pathway
Detailed Description:
This is a multi-centerrandomizedphase 3 clinical trial In the study HER2-positive metastatic breast cancer patients with abnormal activation of PI3KAktmTOR pathway after progression on trastuzumab are enrolled and randomized to receive the treatment of Inetetamab plus Rapamycin plus chemotherapy or Pyrotinib plus chemotherapyThe 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 PI3KAktmTOR pathway after progression on trastuzumab The primary end point is Progressive-free Survival PFS The secondary end points are Overall Response Rate ORROverall Survival OSClinical Benefit Rate CBR and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None