Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05800756
Status:
RECRUITING
Last Update Posted:
2023-04-06
First Post:
2023-03-23
Brief Title:
Pyrotinib Combined With TrastuzumabDalpiciclib and Letrozole for HRHER2 Breast Cancer
Sponsor:
Yantai Yuhuangding Hospital
Organization:
Yantai Yuhuangding Hospital
Study Overview
Official Title:
Pyrotinib Combined With Trastuzumab Dalpiciclibe and Letrozole for HRHER2 Breast CancerA Single Arm Open Label Phase II Trial
Status:
RECRUITING
Status Verified Date:
2023-03
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:
In this single arm open label phase 2 trial operable patients with stage II-III HRHER2 breast cancer will be enrolled and receive two cycles of pyrotinib combined with trastuzumab dalpiciclib and letrozole Imaging evaluation was performed two weeks later and patients who achieved CR or PR were continued with the original regimen for 4 cycles Subjects who did not achieve PR switched to regimen and received 4 cycles of pyrotinib combined with trastuzumab plus chemotherapy This study aims to assessed the biological effects and safety of pyrotinib combined with trastuzumab dalpiciclib and letrozole for HRHER2 breast cancer in the neoadjuvant setting
Detailed Description:
This is a single arm open label phase 2 trial aimed to investigate the biological effects and safety of pyrotinib combined with trastuzumab dalpiciclib and letrozole for HRHER2 breast cancer A total of 30 patients with stage II-III HRHER2 breast cancer will be enrolled Subjects will be enrolled and receive two cycles of pyrotinib combined with trastuzumab dalpiciclib and letrozole Imaging evaluation was performed two weeks later and patients who achieved CR or PR were continued with the original regimen for 4 cycles Subjects who did not achieve PR switched to regimen and received 4 cycles of pyrotinib combined with trastuzumab plus chemotherapy In a specific medication cycle patients use dalpiciclib orally 125mg day 1-21 and letrozole orally 25 mg day 1-28 and pyrotinib orally 320mg day 1-28 and trastuzumab injection 8 mgkg loading dose in cycle 1 6mgkg in cycles 2-6 intravenous drops 1 cycle on day 1-21 Premenopausal or perimenopausal patients should combine ovarian function suppression including bilateral oophorectomy or treatment with gonadotropin-releasing hormone agonists The primary endpoint is pathological complete response rate The secondary endpoints include overall response rate breast-conserving surgery rate and safety profile
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