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RecruitingNCT06500494

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

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

Sponsor

Pierre Fabre Medicament

Enrollment

368 participants

Start Date

Sep 10, 2024

Study Type

OBSERVATIONAL

Conditions

Advanced Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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

Interventions

DRUGVinorelbine 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.

Locations(3)

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

Algiers, Algeria

Tianjing Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Azienda Ospedaliera San Gerardo U.O. Oncologia Medica

Monza, Italy

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NCT06500494

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