Ignite Creation Date:
2024-05-06 @ 4:18 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04943497
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2021-06-21
Brief Title:
A Prospective Observational Study to Describe Clinical Outcomes Treatment Patterns Patients Characteristics Among Patients With HRHER2- Advanced BC Initiating Treatment With Risarg Piqray Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Prospective Observational Study to Describe Clinical Outcomes Treatment Patterns Patients Characteristics Among Patients With HRHER2- Advanced BC Initiating Treatment With Risarg Ribociclib Piqray Alpelisib Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia
Status:
RECRUITING
Status Verified Date:
2024-02
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:
PROSPERITY
Brief Summary:
This study is planned as a prospective multicenter NIS This study is observational in nature and does not impose a therapy protocol diagnostictherapeutic interventions or a visit schedule Patients with HR HER2- advanced or metastatic BC that initiated treatment with ribociclib alpelisib mono endocrine therapy or chemotherapy will be included into the study across seven Russian districts
Detailed Description:
Patients will attend the sites in accordance with routine clinical practice It is assumed that visits will be conducted every 3-4 months Patients will undergo standard procedures and tests according to clinical guidelines and physicians judgement Available data from routine clinical management of the patients will be collected at patients visits to the clinical site Patients enrolled in the study will be followed up until death or study close whichever occurs first The recruitment period is planned for 24 months observation period for maximum of 24 months with total duration of study 4 years Patients may discontinue from this NIS at any time
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