Ignite Creation Date:
2024-05-06 @ 6:11 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05577442
Status:
UNKNOWN
Last Update Posted:
2022-10-19
First Post:
2022-10-09
Brief Title:
Trastuzumab Pyrotinib Combined With Dalpiciclib and Endocrine Therapy for HR HER2 Advanced Breast Cancer
Sponsor:
Peking University Cancer Hospital Institute
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
Peking University Cancer Hospital Institute
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
NOT_YET_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 study investigates the efficacy and safety of trastuzumab pyrotinib combined with dalpiciclib and endocrine therapy for patients with advanced HRHER2 brest cancer providing more possible effective regimens for the survival benefit of these patients in clinical practice
Detailed Description:
This study is a single-arm open-label multicenter phase II clinical study Subjects were eligible for screening and entered the trial period after enrollment and received treatment with pyrotinib320mgday trastuzumab8 mg6mgevery 3 week dalpiciclib125mg once daily for 3 weeks followed by 1 week off in each 4-week cycle endocrine therapy until disease progression or intolerable toxicity or withdrawal of informed consent or discontinuation of medication at the investigator s discretion On-study imaging assessments were performed according to RECIST 11 criteria and the site assessment was final
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