Ignite Creation Date:
2024-05-06 @ 1:17 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03980054
Status:
UNKNOWN
Last Update Posted:
2021-05-24
First Post:
2019-06-06
Brief Title:
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Phase III Study to Evaluate the Efficacy and Safety of Pyrotinib Versus Placebo in Patients With Human Epidermal Growth Factor Receptor 2 HER2 Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
ACTIVE_NOT_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:
None
Brief Summary:
This is a randomised double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab The main purpose of this study is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab
Detailed Description:
None
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