Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05969184
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2022-12-14
Brief Title:
Palbociclib Combine With Anti-HER2 Therapy in Triple Positive ABC
Sponsor:
Peking University Cancer Hospital Institute
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
Palbociclib Combine With Endocrine Therapy and Anti-HER2 Therapy in HR Positive and HER2 Positive Advanced Breast Cancer
Status:
RECRUITING
Status Verified Date:
2023-07
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 study is to find out that if HER-2 positive and HR positive patients could benefit from trastuzumab and pertuzumab combined with palbociclib and endocrine therapy
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 palbociclib125mgday trastuzumab8 mg6mgevery 3 week pertuzumab840 mg420mgevery 3 week combined with 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?:
True
Is an FDA AA801 Violation?:
None