Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04901299
Status:
WITHDRAWN
Last Update Posted:
2023-08-01
First Post:
2021-05-18
Brief Title:
Fulvestrant Neratinib In Breast Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
An Open-Label Phase II Trial of Fulvestrant And Neratinib in Previously Treated HRPositive HER2-Negative Metastatic Breast Cancer Subjects Assessed With a Test Measuring Live Cell HER2 Signaling Function
Status:
WITHDRAWN
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Team decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HER2-Signal
Brief Summary:
This is a Phase 2 open label multi-center non-randomized interventional study designed to evaluate the safety and efficacy of combining Neratinib plus Fulvestrant in previously treated metastatic HR-positive HER2-negative breast cancer
This research study involves the study drug Neratinib
The standard of care drug Fulvestrant
This research study involves the study drug Neratinib
The standard of care drug Fulvestrant
Detailed Description:
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits
This research study involves the study drug Neratinib
The standard of care drug Fulvestrant
It is expected that about 25 people will take part in this research study
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved Neratinib for this specific disease but it has been approved for other uses
The FDA has approved Fulvestrant as a treatment option for this disease Fulvestrant is a standard of care drug that will be administered
This research study involves the study drug Neratinib
The standard of care drug Fulvestrant
It is expected that about 25 people will take part in this research study
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved Neratinib for this specific disease but it has been approved for other uses
The FDA has approved Fulvestrant as a treatment option for this disease Fulvestrant is a standard of care drug that will be administered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None