Ignite Creation Date:
2024-05-06 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05075512
Status:
RECRUITING
Last Update Posted:
2021-10-12
First Post:
2021-08-09
Brief Title:
The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
A Prospective Study on Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With HR-positive and HER2-negative Secondary Endocrine-resistant Locally Advanced or Metastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2021-10
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 management of HR-positive HER2-negative metastatic breast cancer includes endocrine monotherapy or combination regimens both with benefit diminishing as resistance develops Nowadays various studies have demonstrated that estrogen interacts with many angiogenic pathways and is an important mechanism for resistance leading to the question of whether combination with antiangiogenesis and antiestrogen therapies could be an appropriate therapeutic modality Anlotinib is a novel multi-target tyrosine kinase inhibitor that effectively inhibit VEGFR FGFR PDGFR c-KIT c-MET and RET Previous studies have proven the efficacy of both anlotinib monotherapy and combination regimens in advanced breast cancer This phase II study aims to preliminarily evaluate the efficacy and safety of anlotinib combined with endocrine therapy
Detailed Description:
This study is a prospective single-arm open-label phase II clinical trial The secondary endocrine-resistant is defined as disease relapse within 12 months after at least 24 months endocrine adjuvant therapy or disease progress after at least 6 months endocrine salvage therapy Eligible patients were treated with oral anlotinib plus intramuscular fulvestrant till disease progression or intolerant toxicity In the part of statistical analysis 40 patients are required to have a 80 power to detect significant improvement in median progression-free survival from 58 fulvestrant alone to 10 fulvestrant combined with anlotinib months if tested at a two-sided significance level of α005
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