Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475443
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-22
Brief Title:
Efficacy of Pyrotinib Plus Capecitabine in HER2-positive MBC With Active Brain Metastases That Have Failed ADCs
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
The Efficacy and Safety of Pyrotinib Plus Capecitabine in Human Epidermal Growth Factor Receptor 2-positive Breast Cancer Patients With Active Brain Metastases That Have Failed Antibody-drug ConjugateADC a Prospective Single Arm Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
To evaluate the efficacy and safety of pyrotinib plus capecitabine in HER2-positive breast cancer patients with active brain metastases that have failed ADCs
Detailed Description:
To evaluate the efficacy and safety of pyrotinib plus capecitabine in Human Epidermal Growth Factor Receptor 2HER2-positive breast cancer patients with active brain metastases that have failed Antibody Drug ConjugatesFam-trastuzumab deruxtecan-nxkiT-DXd or A1811 had received no local radiotherapy previously and have at least one measurable brain lesion according to response assessment in neuro-oncology RANOcriteria
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