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

Sponsor
Pierre Fabre Medicament
Study ID
NCT06500494
Status
Recruiting
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Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Sep 10, 2024
Status verified
Jul 2025
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
368 participants (estimated)

Arms

  • Arm: Retrospective Cohort
    Patients who initiated an oral vinorelbine treatment for advanced breast cancer over the 2011-2020 targeted enrollment period
  • Arm: 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

Primary Outcome Measure

PFS rate in both cohorts. [ Time Frame: 2-years follow-up ]

Central Contacts

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