Clinical trial NCT06500494: To Describe How Well Vinorelbine Given Orally Works in Patients With a Breast Cancer After 2 Years of Treatment
Official title: Advanced Breast Cancer Patients Treated With Oral Vinorelbine: a Prospective and Retrospective, Observational Study - VINOREAL
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Advanced Breast Cancer
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2024-07-15
Enrollment: 368
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include advanced breast cancer (ABC) patients treated with Oral Vinorelbine in any line of treatment and living in one of the target countries (Italy, China and Algeria).

ABC includes locally advanced breast cancer and metastatic breast cancer either newly diagnosed or a relapse.

The retrospective cohort will include 130 patients who initiated oral vinorelbine-based therapy (OV) in any line of treatment between 2011 and 2020, whether they are alive, have progressed or have died by the time of data collection.

The prospective cohort will include 238 patients for whom it is planned, at the time of study enrollment, to receive oral vinorelbine in any line of treatment.

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.

Eligibility 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

Primary outcomes:
measure: PFS rate in both cohorts.
timeFrame: 2-years follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pierre Fabre Medicament
name: Eric Garrigue, MD
role: STUDY_CHAIR
References: