Ignite Creation Date:
2024-05-06 @ 1:01 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03910712
Status:
UNKNOWN
Last Update Posted:
2019-04-10
First Post:
2019-04-03
Brief Title:
Pyrotinib Combined With Trastuzumab and AI in the First-line Treatment of HER2 Positive HR Positive MBC
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Randomized Open-label Study of First Line Pyrotinib Trastuzumab With an Aromatase Inhibitors in the Treatment of HER2 Positive and HR Positive Metastatic or Inoperable Locally Advanced Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2019-04
Last Known Status:
NOT_YET_RECRUITING
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:
Pyrotinib
Brief Summary:
This study is a randomized open-label phase II study comparing the efficacy and safety of trastuzumab plus aromatase inhibitors with or without pyrotinib in the treatment of HR hormone receptorHER2 human epidermal growth factor receptor 2 MBC and inoperable LABC patients
Detailed Description:
This is a randomized two-arm open-label multicenter phase II trial Our primary purpose is to compare that PFS of patients with trastuzumab AI plus pyrotinib and trastuzumab plus an AI for HER2-positive and hormone receptor-positive MBC or locally advanced breast cancer LABC
Eligible patients will randomized to a ratio of 11 to pyrotinib trastuzumab aromatase inhibitor experimental group or trastuzumabaromatase inhibitor control group Stratification factors were 1time since adjuvant hormone therapy 12 months12 monthsno prior hormone therapy 2 lesion visceral non-visceral
In treatment period patients will be administrated trastuzumab plus aromatase inhibitors with or without pyrotinib every 21 days for 1 cycle until disease progression toxicity intolerance withdrawal of informed consent patients judged must be terminated study termination
The imaging evaluation was performed according to the RECIST 11 criteria every 6 weeks
Eligible patients will randomized to a ratio of 11 to pyrotinib trastuzumab aromatase inhibitor experimental group or trastuzumabaromatase inhibitor control group Stratification factors were 1time since adjuvant hormone therapy 12 months12 monthsno prior hormone therapy 2 lesion visceral non-visceral
In treatment period patients will be administrated trastuzumab plus aromatase inhibitors with or without pyrotinib every 21 days for 1 cycle until disease progression toxicity intolerance withdrawal of informed consent patients judged must be terminated study termination
The imaging evaluation was performed according to the RECIST 11 criteria every 6 weeks
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?:
False
Is an FDA AA801 Violation?:
None