Ignite Creation Date:
2024-05-06 @ 1:28 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04034589
Status:
UNKNOWN
Last Update Posted:
2020-12-22
First Post:
2019-07-21
Brief Title:
Pyrotinib in Combination With Fulvestrant in Patients With HER2 PositiveHR-Positive Metastatic Breast Cancer
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Phase II Study of Pyrotinib in Combination With Fulvestrant in Patients With Human Epidermal Growth Factor Receptor 2 HER2 PositiveHormone ReceptorHR-Positive Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
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:
HRHER2Human epidermal growth factor receptor 2 positive and hormone receptor positivemetastatic breast cancer is a special subtype of HER2breast cancer Conventional guidelines recommend chemotherapy combined with trastuzumab targeted therapy for this subtype of patients However the choice of treatment for these patients after treatment progress is a research hotspot in this field Pyrotinib is a new class I small molecule Tyrosine kinase inhibitorsTKI drug with high efficacy and low toxicity after the progress of trastuzumab therapy Fulvestrant is the most preferred single-drug therapy for HR metastatic breast cancer recommended unanimously by the guidelines and fulvestrant and small molecule TKI have synergistic effects Therefore we envisage that fulvestrant combined with Pyrotinib in the treatment of HRHER2 metastatic breast cancer in clinical practice has the advantages of improving efficacy and survival To this end we intend to conduct a prospective multi-center phase II clinical trial to evaluate the efficacy and safety of erlotinib in combination with fulvestrant in patients with human epidermal growth factor receptor 2 HER2 positivehormone receptor-positive metastatic breast cancer
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