Ignite Creation Date:
2024-05-06 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05328440
Status:
RECRUITING
Last Update Posted:
2023-09-25
First Post:
2022-03-14
Brief Title:
Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2 Advanced Breast CancerDAP-Her-02
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2 Advanced Breast Cancer a Single Arm Dual Cohort Prospective Open Phase II Exploratory Study
Status:
RECRUITING
Status Verified Date:
2023-09
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:
Based on different HR status we explored the efficacy and safety of Pyrotinib and Dalpiciclib Isethionate Tablets based combination regimen in the first-line treatment of HER2 MBC
Detailed Description:
Cyclin D-CDK46-RB-E2F signaling pathway regulates the transformation of breast cancer cells from stage G1 to S and plays an important role in the proliferation of breast cancer cells HER2 protein regulates proliferation of breast cancer cells through PI3KAKT signaling pathway HER2 positive breast cancer patients need anti HER2 therapy Data indicate that HER2 positive breast cancer patients often express cyclin D1 and E1 suggesting that anti HER2 therapy can synergy with CDK46 inhibitors
A preclinical study shows that the combination of CDK46 inhibitor Dulcie and anti HER2 drug pyrrolidone can effectively reduce the phosphorylation of AKT and HER3 thereby promoting the apoptosis of HER2 positive breast cancer cells and achieving the purpose of inhibiting tumor
In the clinical study of na-phere 2 piperacillin combined with trastuzumab patuzumab and fluvestrant can significantly inhibit the expression of Ki67 MonarcHER study shows that the treatment of patients with advanced HRHER2 breast cancer after the failure of anti HER2 is better than conventional chemotherapy plus anti HER2 therapy The successful challenge of traditional chemotherapy is the opening of a new chapter in the treatment of HRHER2 In 2021 ESMO 276P reported the interim data of darcilil combined with pyrroltinib in the first-line second-line treatment of MBC HR - HER2 MBC ORR can reach 818 and the safety is controllable
Based on different HR status we explored the efficacy and safety of Pyrotinib and Dalpiciclib Isethionate Tablets based combination regimen in the first-line treatment of HER2 MBC
A preclinical study shows that the combination of CDK46 inhibitor Dulcie and anti HER2 drug pyrrolidone can effectively reduce the phosphorylation of AKT and HER3 thereby promoting the apoptosis of HER2 positive breast cancer cells and achieving the purpose of inhibiting tumor
In the clinical study of na-phere 2 piperacillin combined with trastuzumab patuzumab and fluvestrant can significantly inhibit the expression of Ki67 MonarcHER study shows that the treatment of patients with advanced HRHER2 breast cancer after the failure of anti HER2 is better than conventional chemotherapy plus anti HER2 therapy The successful challenge of traditional chemotherapy is the opening of a new chapter in the treatment of HRHER2 In 2021 ESMO 276P reported the interim data of darcilil combined with pyrroltinib in the first-line second-line treatment of MBC HR - HER2 MBC ORR can reach 818 and the safety is controllable
Based on different HR status we explored the efficacy and safety of Pyrotinib and Dalpiciclib Isethionate Tablets based combination regimen in the first-line treatment of HER2 MBC
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