How oral vinorelbine works in advanced breast cancer over two years
Advanced Breast Cancer Patients Treated With Oral Vinorelbine: a Prospective and Retrospective, Observational Study - VINOREAL
This project will see how well oral vinorelbine works for adult women with advanced breast cancer who have already taken the drug or are starting it now.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 368 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Pierre Fabre Medicament Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Algiers and 2 other locations) |
| Trial ID | NCT06500494 on ClinicalTrials.gov |
What this trial studies
This is an international, multicenter observational program combining a retrospective cohort of patients who started oral vinorelbine between 2011 and 2020 with a prospective cohort of new initiators. Retrospective patients are followed from treatment start until death, last contact, or the retrospective cutoff, while prospective patients will be followed for up to about two years after treatment initiation. No extra clinic visits or procedures beyond routine oncology care are required, and prospective participants will complete quality-of-life (QoL), patient preference (PPQ), and work productivity (WPAI) questionnaires. The study aims to describe real-world use, outcomes, and tolerability of oral vinorelbine in locally advanced or metastatic breast cancer across participating centers.
Who should consider this trial
Good fit: Adult women with confirmed locally advanced or metastatic breast cancer who have started or will start oral vinorelbine and can provide consent and complete QoL questionnaires are ideal candidates.
Not a fit: Patients not receiving oral vinorelbine, those with early-stage disease, or individuals unable to provide consent or complete questionnaires are unlikely to benefit from enrolling.
Why it matters
Potential benefit: If patterns show favorable outcomes, the results could help doctors and patients make more informed choices about using oral vinorelbine in advanced breast cancer.
How similar studies have performed: Oral vinorelbine has been reported in prior clinical and observational studies with activity in metastatic breast cancer, so this study builds on existing, though not definitive, evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Female aged ≥ 18 years (≥ 19 years for Algeria as per local regulation) at oral vinorelbine ( OV) -based treatment initiation Confirmed diagnosis of locally advanced or metastatic breast cancer eligible for chemotherapy Initiated OV-based treatment as per SmPC for advanced breast cancer between January 2011 and December 2020 for the retrospective cohort or, initiating oral vinorelbine treatment at enrollment for the prospective cohort Willing and able to complete the QoL questionnaire, PPQ and WPAI questionnaire for the prospective cohort Provision of informed consent or non-opposition to the patient (or next of kin/legal representative, if applicable) for the use of data, according to local regulations Exclusion Criteria: no exclusion criteria for patients in this study
Where this trial is running
Algiers and 2 other locations
- Centre Hospitalo-Universitaire Mustapha, Hopital Mustapha, Place du 1er Mai 1945, Sidi M'Hamed — Algiers, Algeria (Recruiting)
- Tianjing Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
- Azienda Ospedaliera San Gerardo U.O. Oncologia Medica — Monza, Italy (Recruiting)
Study contacts
- Study coordinator: Cynthia Mourad, PharmD
- Email: cynthia.mourad@pierre-fabre.com
- Phone: +33 6 31 02 00 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.