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

Pierre Fabre

Status: Enrolling

Conditions: Advanced Breast Cancer

Treatments: Drug: Vinorelbine Tartrate Oral

Study type: Observational

Funder types: Industry

Identifiers

NCT06500494

NIS16760

Details and patient eligibility

About

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.

Full 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.

Enrollment: 368 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

368 participants in 2 patient groups

Retrospective Cohort

Description:

Patients who initiated an oral vinorelbine treatment for advanced breast cancer over the 2011-2020 targeted enrollment period

Treatment:

Drug: Vinorelbine Tartrate Oral

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

Treatment:

Drug: Vinorelbine Tartrate Oral