Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625333
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
A Prospective Non-interventional Study to Evaluate Clinical Outcomes of Ribociclib Combined With Endocrine Therapy in Elderly Patients With HRHER2 - Advanced Breast Cancer in Routine Clinical Practice in Russian Federation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Non-interventional Study to Evaluate Clinical Outcomes of Ribociclib Combined With Endocrine Therapy in Elderly Patients With HRHER2 - Advanced Breast Cancer in Routine Clinical Practice in Russian Federation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARFENOPA
Brief Summary:
This is а prospective non-interventional primary data collection study to evaluate the effectiveness safety and quality of life in older patients 65 years with HRHER2- advanced breast cancer receiving ribociclib with ET in the first or second line in the real-life settings in Russia
Detailed Description:
In this study an index event is a start of ribociclibET treatment Post-index follow-up period is 24 months or until treatment discontinuation The recruitment period is planned for 12 months The interim analyses will be performed after enrollment is complete and further one year later Patients will visit the sites in accordance with routine clinical practice It is assumed according to the clinical practice that visits will be conducted every 3-4 months Patients will undergo standard procedures and tests according to clinical guidelines and physicians judgement
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