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

NCT06500494 | Recruiting

• 1 other identifier: NIS16760
• Study Type: observational
• Target: 368
• Locations: 3 countries
• Sites: 3

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.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Retrospective Cohort

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

Drug: Vinorelbine Tartrate Oral

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

Interventions

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.

Also known as: Navelbine

Prospective Cohort; Retrospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (3)

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

Algiers, 16000, Algeria

RECRUITING

Tianjing Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 360060, China

RECRUITING

Azienda Ospedaliera San Gerardo U.O. Oncologia Medica

Monza, 20052, Italy

RECRUITING

MeSH Terms

Interventions

Vinorelbine

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Eric Garrigue, MD

  Pierre Fabre Medicament

  STUDY CHAIR

Central Study Contacts

Cynthia Mourad, PharmD

CONTACT

+33 6 31 02 00 69; cynthia.mourad@pierre-fabre.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); IT (1); AL (1)