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Oral chemotherapy pill tested for advanced breast cancer

NCT ID NCT06500494

Disease control Sponsor: Pierre Fabre Medicament Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study looks at how well oral vinorelbine, a chemotherapy pill, works in women with advanced breast cancer. It includes women who have already taken the drug or are starting it now. Researchers track how long the cancer stays under control and how patients feel during treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral vinorelbine (Navelbine)
What this could lead to
If results are positive, this could confirm oral vinorelbine as a reliable chemotherapy option for advanced breast cancer, offering a convenient at-home treatment.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection or other treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 368 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced breast cancer

Contacts and locations

Locations

  • Azienda Ospedaliera San Gerardo U.O. Oncologia Medica

    Monza, 20052, Italy

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

    Algiers, 16000, Algeria

  • Tianjing Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 360060, China

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