Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:09 AM
Study NCT ID:
NCT07470203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer
Sponsor:
Peking University Cancer Hospital & Institute
Organization:
Study Overview
Official Title:
Efficacy and Safety of Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer：A Prospective, Single-Arm, Observational, Real-World Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
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 Prospective, Single-Arm, Observational, Real-World Study. The purpose of this study is to evaluate the safety and efficacy of pyrotinib combined with trastuzumab and pertuzumab for maintenance therapy in HER2-positive advanced breast cancer in the real-world setting.
Detailed Description:
The current standard of care for first-line treatment of HER2+ advanced breast cancer consists of induction chemotherapy with a taxane (T) in combination with dual anti-HER2 monoclonal antibody, trastuzumab (H) and pertuzumab (P), followed by maintenance therapy with HP. However, most patients eventually experience disease progression on this regimen and not all will be able to receive a second-line treatment. The aim of this study was to evaluate the efficacy and safety of pyrotinib combined with HP as maintenance therapy for HER2-positive advanced breast cancer patients. The results are expected to provide real-world evidence for optimizing first-line maintenance treatment strategies in patients with HER2+ advanced breast cancer who had completed induction therapy with THP.
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?: