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Monitoring the Effects of Epirubicin, Cyclophosphamide, and Docetaxel in Women with Breast Cancer

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What is this trial about?

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

This clinical trial focuses on studying the treatment of breast cancer using several commonly used medications. The medications being studied include Docetaxel, Cyclophosphamide, Epirubicin, Paclitaxel, and Doxorubicin. These drugs are often used in the routine treatment of breast cancer, and the study aims to monitor their effects to better understand how they work and how they might be adjusted for individual patients in the future.

The purpose of the study is to measure the levels of these drugs in the body and to see how they relate to side effects and treatment outcomes. This information could help doctors adjust doses for future patients to avoid giving too much or too little of the medication. The study will involve monitoring patients who are receiving these drugs as part of their breast cancer treatment. The researchers will look for patterns between the amount of drug exposure and various health effects, such as blood health, liver function, heart health, and overall quality of life.

Throughout the study, participants will receive their usual breast cancer treatments, and the researchers will collect information on how the drugs affect them. The study will also explore whether certain genetic factors might influence how patients process these drugs, which could help identify those at risk of receiving too much or too little medication. The ultimate goal is to improve treatment by tailoring drug doses to each patient's needs, potentially leading to better outcomes and fewer side effects.

The research process

The trial runs in 7 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, participation is confirmed through written informed consent. Eligibility is determined based on age (18 years or older) and treatment with specific drugs for breast cancer.

  2. Step 2

    Treatment administration

    The treatment involves the administration of cytostatic drugs, which are used to treat breast cancer. These drugs include docetaxel, cyclophosphamide, epirubicin hydrochloride, paclitaxel, and doxorubicin hydrochloride.

    All medications are given through infusion, which means they are delivered directly into the bloodstream through a vein.

  3. Step 3

    Monitoring and dose adjustment

    The main objective is to monitor the levels of these drugs in the body and adjust doses to avoid over- or under-treatment. This involves measuring drug exposure and observing any side effects.

    The study aims to find correlations between drug exposure and various factors such as side effects, quality of life, and tumor response.

  4. Step 4

    Evaluation of side effects

    The primary endpoint is to measure the occurrence of mild anemia in patients treated with epirubicin and cyclophosphamide.

    Secondary endpoints include identifying correlations between drug exposure and other side effects, such as effects on blood, liver, heart, and ovaries.

  5. Step 5

    Genetic and lifestyle factors

    The study also explores how genetic factors and lifestyle choices, such as body weight, age, and smoking habits, may affect drug metabolism and exposure.

  6. Step 6

    Outcome assessment

    The study assesses various outcomes, including survival rates, recurrence of cancer, and the prevalence of severe side effects based on drug exposure levels.

    It also examines the impact of drug exposure on healthcare needs, employment, and recovery time.

  7. Step 7

    Completion of the study

    The estimated end date for the study is December 31, 2026. Throughout the study, data is collected to improve future treatment strategies for breast cancer patients.

Who can join the trial?

4 criteria

  • Must be a female patient.
  • Must be 18 years or older.
  • Must be receiving treatment with any of the following drugs: cyclophosphamide, epirubicin, doxorubicin, docetaxel, or paclitaxel. These are medications commonly used to treat breast cancer.
  • Must provide written informed consent, which means agreeing to participate in the study after being fully informed about it.

Who cannot join the trial?

4 criteria

  • Men cannot participate in the study. Only women are eligible.
  • Individuals who are not within the specified age range cannot participate. The study is for certain age groups only.
  • People with medical conditions other than **breast cancer** cannot participate. The study is specifically for those with breast cancer.
  • Individuals who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate.
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Investigated drugs

  • Epirubicin

    is a medication used in the treatment of breast cancer. It works by interfering with the growth of cancer cells, slowing their spread in the body. In this trial, its levels in the body are monitored to understand its effects and side effects better.

  • Cyclophosphamide

    is a chemotherapy drug used to treat various types of cancer, including breast cancer. It works by slowing or stopping the growth of cancer cells. The trial aims to monitor its concentration in the body to help tailor the dosage for individual patients.

  • Docetaxel

    is a chemotherapy medication used to treat breast cancer. It works by preventing cancer cells from dividing and growing. The study measures its presence in the body to find the best dosage for each patient, minimizing side effects.

  • Paclitaxel

    is a drug used in chemotherapy to treat breast cancer. It helps stop the growth of cancer cells by interfering with their division. The trial focuses on monitoring its levels to adjust doses for better treatment outcomes.

  • Doxorubicin

    is a chemotherapy medication used to treat breast cancer. It works by slowing or stopping the growth of cancer cells. The trial involves measuring its concentration in the body to help determine the most effective and safe dosage for patients.

What is already known about the treatment

  • Epirubicin

    Epirubicin is administered intravenously and is currently used in the treatment of breast cancer. It is well-documented in medical literature as a chemotherapy agent. The main therapeutic indication is for breast cancer, where it works by interfering with the DNA of cancer cells, preventing their growth and division. It belongs to the pharmacological class of anthracyclines.

  • Cyclophosphamide

    Cyclophosphamide is given intravenously or orally and is widely used in the treatment of breast cancer. It is a well-established medication in medical literature. Its primary use is to treat breast cancer by damaging the DNA of cancer cells, which stops them from multiplying. It is classified as an alkylating agent.

  • Docetaxel

    Docetaxel is administered intravenously and is a common treatment for breast cancer. It is well-recognized in medical literature. The main therapeutic indication is breast cancer, where it works by disrupting the microtubule network in cells, which is essential for cell division. It is part of the taxane class of drugs.

  • Paclitaxel

    Paclitaxel is given intravenously and is used in the treatment of breast cancer. It is well-documented in medical literature. Its primary indication is for breast cancer, where it acts by stabilizing the microtubule polymer and protecting it from disassembly, which inhibits cell division. It belongs to the taxane class of medications.

  • Doxorubicin

    Doxorubicin is administered intravenously and is a well-known treatment for breast cancer. It is extensively covered in medical literature. The main therapeutic indication is breast cancer, where it works by intercalating DNA strands, thereby inhibiting the replication of cancer cells. It is classified as an anthracycline antibiotic.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump or seen on an X-ray. It primarily affects women, although men can also develop it. The disease can start in different parts of the breast, such as the ducts or lobules, and may spread to other parts of the body if not treated. As it progresses, breast cancer can cause changes in breast size or shape, skin dimpling, or nipple discharge. The progression of the disease varies, with some types growing slowly and others more rapidly. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514818-12-00Protocol codeTailorDose-IIEstimated enrolment200 patientsSponsorKarolinska Institutet

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