Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04582968
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-01-18
First Post:
2020-10-07
Brief Title:
Pyrotinib Combined With Brain Radiotherapy in Breast Cancer Patients With Brain Metastases
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Phase IbII Pilot Study of Pyrotinib Plus Capecitabine Combined With Brain Radiotherapy in HER2 Positive Breast Cancer Patients With Brain Metastases
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-01
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:
Brain metastases occur in 30-50 of patients with metastatic HER2-positive breast cancer Pyrotinib is an irreversible pan-ErbB receptor tyrosine kinase inhibitor TKI with activity against epidermal growth factor receptor EGFRHER1 HER2 and HER4 This study consists of two parts In a phase Ib part investigators will explore the safety and tolerance of Pyrotinib Plus Capecitabine combined with brain radiotherapy After completing the phase Ib part investigators will review the data and decide whether this patient is included in before the start of a phase II part In the phase II part investigators will evaluate the efficacy of Pyrotinib Plus Capecitabine combined with brain radiotherapy in patients with HER2 positive breast cancer patients with brain metastases
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