Ignite Creation Date:
2024-05-06 @ 2:41 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04396626
Status:
TERMINATED
Last Update Posted:
2023-04-27
First Post:
2020-04-28
Brief Title:
HR HER2- Advanced Metastatic Breast Cancer Real World Treatment Patterns and Outcomes
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Patient Characteristics Treatment Patterns and Clinical Outcomes in Patients Diagnosed With HRHER2- AdvancedMetastatic Breast Cancer Receiving CDK46i Aromatase Inhibitor AI Combination Therapy as Initial Endocrine-based Treatment
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was prematurely discontinued due to significant data quality issues on August 26 2021 There were no safety concerns that led to the decision to terminate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a retrospective observational study that will document the treatment patterns and clinical outcomes of patients diagnosed with HRHER2- AMBC who received CDK46i combination therapy with aromatase inhibitors AI as the initial endocrine-based therapy in the AMBC setting
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Concerto | OTHER | Alias Study Number | None |