Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 3:57 PM
Study NCT ID:
NCT06500494
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2024-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
Study Overview
Official Title:
Advanced Breast Cancer Patients Treated With Oral Vinorelbine: a Prospective and Retrospective, Observational Study - VINOREAL
Status:
RECRUITING
Status Verified Date:
2025-07
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?: