Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06313983
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-05
Brief Title:
A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer
Sponsor:
Tianjin Hemay Pharmaceutical Co Ltd
Organization:
Ganzhou Hemay Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase Ⅲ Randomized Open Label Parallel Multicenter To Assess Efficacy and Safety Study of Hemay022 in Combination With AI In Postmenopausal HER2ER Advanced Breast Cancer Patients Treated With Trastuzumab-containing Regimens
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The purpose of this study is to evaluate the effectiveness of Hemay022 combined with AI exemestane or letrozole in the treatment of ERHER2 advanced breast cancer patients based on the progression-free survival PFS assessed by the independent review committee IRC The second purpose of this study is to evaluate the pharmacokinetics and efficacy of Hemay022 in combination with AI and the safety of Hemay022 in combination with AI
The trial plans to recruit 339 subjects who will be randomly divided into two cohorts the experimental group is hemay022 combined with AI and the control group is lapatinib combined with capecitabine During the treatment period imaging examinations and anti-tumor efficacy evaluations will be performed regularly until the subject develop disease progression or starts receiving other treatments or dies or refuses to come to the hospital for follow-up or the trial is terminated etc
The trial plans to recruit 339 subjects who will be randomly divided into two cohorts the experimental group is hemay022 combined with AI and the control group is lapatinib combined with capecitabine During the treatment period imaging examinations and anti-tumor efficacy evaluations will be performed regularly until the subject develop disease progression or starts receiving other treatments or dies or refuses to come to the hospital for follow-up or the trial is terminated etc
Detailed Description:
None
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