NCT06500494

To Describe How Well Vinorelbine Given Orally Works in Patients With a Breast Cancer After 2 Years of Treatment

Advanced Breast Cancer Patients Treated With Oral Vinorelbine: a Prospective and Retrospective, Observational Study - VINOREAL

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 368 (estimated)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Vinorelbine Tartrate Oral	The recommended dosage for oral vinorelbine is 60 mg/m² of body surface area (BSA) administered once weekly for the first three weeks, followed by 80 mg/m² of BSA for the following weekly administration.

Timeline

• Start date: 2024-09-10
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2024-07-15
• Last updated: 2025-07-24

Locations

3 sites across 3 countries: Algeria, China, Italy