Status:
RECRUITING
To Describe How Well Vinorelbine Given Orally Works in Patients With a Breast Cancer After 2 Years of Treatment
Lead Sponsor:
Pierre Fabre Medicament
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- no exclusion criteria for patients in this study
Key Trial Info
Start Date :
September 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT06500494
Start Date
September 10 2024
End Date
February 1 2028
Last Update
July 24 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalo-Universitaire Mustapha, Hopital Mustapha, Place du 1er Mai 1945, Sidi M'Hamed
Algiers, Algeria, 16000
2
Tianjing Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 360060
3
Azienda Ospedaliera San Gerardo U.O. Oncologia Medica
Monza, Italy, 20052