Ignite Creation Date:
2024-07-17 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
To Describe How Well Vinorelbine Given Orally Works in Patients With a Breast Cancer After 2 Years of Treatment
Sponsor:
Pierre Fabre Medicament
Organization:
Pierre Fabre Medicament
Study Overview
Official Title:
Advanced Breast Cancer Patients Treated With Oral Vinorelbine a Prospective and Retrospective Observational Study - VINOREAL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
VINOREAL
Brief Summary:
This study looks at how well oral vinorelbine works in treating advanced breast cancer It looks at women who have already had this treatment or are currently having it
Detailed Description:
This is an international multicenter retrospective and prospective observational study
The study will comprise of two cohorts
Retrospective Patients who started OV treatment for ABC between 2011 and 2020 will be enrolled in the retrospective cohort study The observation period for retrospectively included patients will extend from the initiation of OV treatment to the date of death date of last contact or end date of retrospective observation period whichever occurs first The end date of retrospective observation period will be set as the date of the inclusion of the first patient in the study First Patient In FPI
Prospective Patients initiating OV treatment and eligible for prospective collection of QoL data and PPQ and WPAI questionnaires will be enrolled in the prospective cohort study The enrollment period is expected to extend up to 17 months from study start The study observation period will extend up to 2 years after last patient first visit around 24 months after treatment initiation
Due to the observational nature of this study no additional medical procedures or in person clinical visits beyond routine oncology care will be required for this study
The study will comprise of two cohorts
Retrospective Patients who started OV treatment for ABC between 2011 and 2020 will be enrolled in the retrospective cohort study The observation period for retrospectively included patients will extend from the initiation of OV treatment to the date of death date of last contact or end date of retrospective observation period whichever occurs first The end date of retrospective observation period will be set as the date of the inclusion of the first patient in the study First Patient In FPI
Prospective Patients initiating OV treatment and eligible for prospective collection of QoL data and PPQ and WPAI questionnaires will be enrolled in the prospective cohort study The enrollment period is expected to extend up to 17 months from study start The study observation period will extend up to 2 years after last patient first visit around 24 months after treatment initiation
Due to the observational nature of this study no additional medical procedures or in person clinical visits beyond routine oncology care will be required for this study
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