Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
Study NCT ID:
NCT06718335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-11
First Post:
2024-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pyrotinib in HER2-positive Early Breast Cancer
Sponsor:
Nie Jianyun
Organization:
Study Overview
Official Title:
Prospective, Multi-cohort, Exploratory Clinical Study of Pyrrotinib Maleate in HER2-positive Early Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-12
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-cohort, Phase II Clinical Study of Neoadjuvant - Adjuvant Pyrotinib in the Treatment of HER2-positive Early Breast Cancer, To evaluate the efficacy and safety of the pyrotinib-containing study regimen in patients with early HER2-positive early breast cancer with neoadjuvant and postoperative different Residual tumor burden (RCB) scores.
Detailed Description:
This is a Multi-cohort, Phase II Clinical Study of Neoadjuvant - Adjuvant Pyrotinib in the Treatment of HER2-positive Early Breast Cancer, To evaluate the efficacy and safety of the pyrotinib-containing study regimen in patients with early HER2-positive early breast cancer with neoadjuvant and postoperative different Residual tumor burden scores.
Study Oversight
Has Oversight DMC:
False
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?: