Advanced Breast Cancer
Conditions
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.
Interventions
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.
Sponsors
Pierre Fabre Medicament
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS rate in both cohorts. | 2-years follow-up | 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 |
Countries
Algeria, China, Italy
Contacts
Primary ContactCynthia Mourad, PharmD
Outcome results
None listed