Clinical trial · Observational
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
NCT06500494CI-TRIAL-00116600VINOREALactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vinorelbine Tartrate Oral | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Retrospective Cohort
- description
- Patients who initiated an oral vinorelbine treatment for advanced breast cancer over the 2011-2020 targeted enrollment period
- interventionNames
- Drug: Vinorelbine Tartrate Oral
- label
- Prospective Cohort
- description
- Patients initiating an oral vinorelbine treatment for advanced breast cancer at or after inclusion in the study and eligible for prospective collection of QoL data and PPQ and WPAI questionnaires
- interventionNames
- Drug: Vinorelbine Tartrate Oral
Primary outcomes (1)
- measure
- PFS rate in both cohorts.
- timeFrame
- 2-years follow-up
- description
- PFS is defined as the time between vinorelbine-based treatment initiation and the first occurrence of progression or death from any cause, with censoring of patients who are lost to follow-up
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.