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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Breast Cancer
• Intervention / Treatment: Drug: Vinorelbine Tartrate Oral

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.

• Study Type: Observational
• Enrollment (Estimated): 368

Contacts and Locations

• Study Contact: Name: Cynthia Mourad, PharmD; Phone Number: +33 6 31 02 00 69; Email: cynthia.mourad@pierre-fabre.com

Study Locations

• Algeria
  • Algiers, Algeria, 16000
    • Recruiting
    • Centre Hospitalo-Universitaire Mustapha, Hopital Mustapha, Place du 1er Mai 1945, Sidi M'Hamed
    • Contact: Esma Kerboua, Pr; Phone Number: 00 213 23559767; Email: esmakerboua@yahoo.fr
• China
  • Tianjin
    • Tianjin, Tianjin, China, 360060
      • Recruiting
      • Tianjing Medical University Cancer Institute & Hospital
      • Contact: Yehui Shi, Pr; Phone Number: (0) 22-23340123; Email: shiyehui@tjmuch.com
• Italy
  • Monza, Italy, 20052
    • Recruiting
    • Azienda Ospedaliera San Gerardo U.O. Oncologia Medica
    • Contact: Marina Elena Cazzaniga, Pr; Phone Number: 0039 02339037; Email: marinaelena.cazzaniga@irccs-sangerardo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective Cohort; Patients who initiated an oral vinorelbine treatment for advanced breast cancer over the 2011-2020 targeted enrollment period	Drug: Vinorelbine Tartrate Oral; 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
Prospective Cohort; 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	Drug: Vinorelbine Tartrate Oral; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS rate in both cohorts.	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	2-years follow-up

Collaborators and Investigators

• Sponsor: Pierre Fabre Medicament
• Investigators: Study Chair: Eric Garrigue, MD, Pierre Fabre Médicament

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Vinorelbine
• Other Study ID Numbers: NIS16760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No