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Study on the Impact of DPYD Gene Test on the Safety and Efficacy of Fluorouracil, Capecitabine, and Tegafur in Finnish Patients with Breast or Colon Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of certain medications on patients with breast cancer and colon cancer. The medications being tested include Teysuno, which contains the active substances tegafur, gimeracil, and oteracil, Capecitabine Orion, which contains capecitabine, and Fluorouracil Accord, which contains fluorouracil. These medications are part of a group known as fluoropyrimidines, which are used in cancer treatment.

The purpose of the study is to understand how a genetic test, called the DPYD gene test, can affect the safety and effectiveness of these cancer treatments. The study will explore whether this test can help identify genetic differences that might influence how well the treatments work and how safe they are for individual patients.

Participants in the study will receive one of the medications mentioned above. The study will monitor the levels of these medications in the blood and assess how the body processes them. This will help researchers learn more about the relationship between genetic factors and the treatment of breast and colon cancer with fluoropyrimidine medications.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, ensure that the informed consent form is signed. This confirms understanding and agreement to participate in the trial.

    Eligibility criteria include being at least 18 years old and having a diagnosis of breast cancer or colon cancer.

  2. Step 2

    Initial testing

    A DPYD gene test is conducted to assess genetic factors that may affect treatment. The results must be available before starting medication.

  3. Step 3

    Medication administration

    The treatment involves taking specific medications. These include Teysuno capsules, Capecitabine tablets, and Fluorouracil infusion.

    Teysuno is taken orally in the form of hard capsules. The dosage and frequency will be provided by the healthcare team.

    Capecitabine is also taken orally as film-coated tablets. The healthcare team will specify the dosage and frequency.

    Fluorouracil is administered through infusion. The healthcare team will determine the dosage and schedule.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring of the concentrations of the medications and their effects is conducted through blood samples.

    The study aims to evaluate the safety and effectiveness of the treatment, considering individual genetic factors.

  5. Step 5

    Completion of the trial

    The trial is expected to continue until December 31, 2025. Participation involves regular check-ins and assessments as outlined by the healthcare team.

Who can join the trial?

5 criteria

  • Signed informed consent: You agree to participate in the study after being informed about it.
  • Age 18 years or older.
  • Diagnosed with breast cancer or colon cancer.
  • Planned treatment with fluoropyrimidine medication: This is a type of drug used in cancer treatment.
  • The result of the DPYD gene test is available before starting fluoropyrimidine medication: This test checks for specific genetic variations that might affect how you respond to the medication.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with breast cancer or colon cancer cannot participate.
  • Patients who are not within the specified age range cannot participate. The study is for adults only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

Fluoropyrimidine is a type of medication used in cancer treatment. It works by interfering with the growth of cancer cells, slowing down or stopping their spread in the body. This medication is often used in chemotherapy to treat various types of cancer, including colorectal and breast cancer. In this clinical trial, the focus is on understanding how genetic testing can improve the safety and effectiveness of fluoropyrimidine therapy for patients.

What is already known about the treatment

Fluoropyrimidine – Fluoropyrimidine is a medication used in the treatment of certain types of cancer, specifically breast and colon cancer. It is typically administered orally or intravenously, meaning it can be taken as a pill or given through a vein. In the body, it works by interfering with the DNA and RNA of cancer cells, which stops them from growing and dividing. This medication is part of a group of drugs known as antimetabolites, which are used to treat cancer by targeting rapidly dividing cells. Currently, research is being conducted to understand how genetic testing, specifically the DPYD gene test, can improve the safety and effectiveness of fluoropyrimidine therapy.

Investigated diseases

  • Breast cancer

    Breast cancer is a disease where cells in the breast grow uncontrollably. It typically begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby lymph nodes or other parts of the body. The growth of cancer cells can form a lump or mass in the breast. Over time, the cancer may invade surrounding tissues and organs. The progression can vary greatly among individuals, with some experiencing slow growth and others more rapid advancement.

  • Colon cancer

    Colon cancer, also known as colorectal cancer, starts in the colon or rectum. It often begins as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. As the disease progresses, it can invade deeper layers of the colon wall and spread to nearby lymph nodes. In advanced stages, colon cancer may metastasize to other organs, such as the liver or lungs. The rate of progression can differ significantly between individuals.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-518448-20-00Estimated enrolment1 000 patientsSponsorHUS-yhtymae

sourced from the EU Clinical Trials Register and site verification

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