Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Personalizing chemo: enzyme test may guide capecitabine dosing

NCT ID NCT04198727

Knowledge-focused Sponsor: Centre Antoine Lacassagne 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how the activity of an enzyme called DPD influences how well the chemotherapy drug capecitabine works in women with metastatic breast cancer. Researchers will measure DPD activity before treatment and track tumor response over 24 months. The goal is to see if DPD levels can predict who benefits most from the drug, potentially leading to more personalized dosing.

What this could mean

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

Active substance
Capecitabine
What this could lead to
If successful, this could help doctors tailor capecitabine doses based on a patient's DPD enzyme activity, improving treatment outcomes and reducing side effects.
What could go wrong
This is a mid-stage study with 155 participants, so results may not apply to all patients. The link between DPD activity and response is not yet proven, and the study is observational in nature.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 155 people

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

Started

Jul 2020

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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: * Age over 18, * Performance status 0 to 2, * Patients with metastatic HER2 negative breast cancer, * Patients eligible for capecitabine monotherapy at a dose of 2000 mg / m² / day, 14 days every 21 days, * Determination of Uracil level performed according to national recommendations, * Patients with at least one lesion evaluable according to the RECIST criteria 1.1, or presenting at least 1 hypermetabolic lesion on PET-TDM according to PERCIST 1.0 criteria. In the case of single cutaneous metastasis (s), it is required to make photographs of lesions with a measure of the lesions using a ruler, * Patients receiving social coverage. Exclusion Criteria: * Performance status\> 2, * Contraindication to capecitabine monotherapy at a dose of 2000 mg / m² / day, 14 days every 21 days, * Presence of untreated or uncontrolled symptomatic cerebral or leptomeningeal metastases (unstable corticosteroid requirements) and / or non-clinically stable in the 3 months prior to inclusion, * History of cancer, with the exception of cancers in complete remission for more than 5 years, totally resected cutaneous basal cell carcinoma, in situ carcinoma or in situ cervical epithelioma treated, * Vulnerable people

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast neoplasm malignant female are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma Her2-receptor negative breast cancer

As listed by the trial registrant

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

Breast neoplasm malignant female

Contacts and locations

Locations

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Azuréen de Cancérologie

    Mougins, 06250, France

  • Clinique Saint Jean

    Cagnes-sur-Mer, 06800, France

  • Clinique St Georges

    Nice, 06105, France

  • Hôpital Princesse Grâce

    Monaco, 98000, Monaco

More trials for these conditions

Other studies related to the condition(s) this trial covers.