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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalo-Universitaire Mustapha, Hopital Mustapha, Place du 1er Mai 1945, Sidi M'Hamed, Algiers, Algeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vinorelbine Tartrate Oral

Drug

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.

Other names: Navelbine

Primary outcomes

PFS rate in both cohorts.

Time frame: 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

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

Advanced Breast Cancer Patients Treated With Oral Vinorelbine: a Prospective and Retrospective, Observational Study - VINOREAL

Acronym: VINOREAL

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2028
First posted: Jul 15, 2024
Registry last updated: Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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