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Study on Cyclophosphamide for Patients with Advanced Breast Cancer with TP53 Mutations

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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 breast cancer, specifically in patients who have a mutation in a gene called TP53. The treatment being tested is a medication called cyclophosphamide, which is given as an injection or infusion. Cyclophosphamide is a type of chemotherapy that works by slowing or stopping the growth of cancer cells. The purpose of the study is to evaluate how well this treatment works in patients with TP53 mutated breast cancer or those with normal TP53 genes.

Participants in the study will receive the treatment over a period of time, with regular monitoring to assess the response of the cancer to the medication. The study aims to understand the effectiveness of cyclophosphamide in shrinking tumors and improving the condition of patients with advanced breast cancer. The trial will also look at the safety and tolerability of the treatment, ensuring that any side effects are carefully managed.

Throughout the study, patients will undergo various tests, such as imaging scans like MRI or CT scans, to measure the size of the tumors and check the overall health of the participants. The study will continue until the researchers gather enough information to determine the treatment's impact on breast cancer with TP53 mutations. This research is important for developing more effective treatments for patients with this type of cancer.

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 trial

    Upon joining the trial, written informed consent is required. This ensures understanding and agreement to participate in the study.

    Eligibility is confirmed through specific criteria, including blood tests and medical history review.

  2. Step 2

    Initial assessments

    Initial assessments include radiology studies to measure the tumor and evaluate cardiac function. These tests must be completed within 28 days before starting treatment.

    A biopsy of the primary tumor or a metastatic lesion is required to determine the TP53 status.

  3. Step 3

    Treatment administration

    The treatment involves the administration of cyclophosphamide, a medication given through an intravenous infusion. This means the medication is delivered directly into the bloodstream through a vein.

    The dosage and frequency of administration are determined by the study protocol and will be explained by the healthcare team.

  4. Step 4

    Ongoing monitoring

    Throughout the trial, regular monitoring is conducted to assess the response to treatment and any side effects. This includes physical exams, blood tests, and imaging studies.

    The healthcare team will provide guidance on managing any side effects experienced during the trial.

  5. Step 5

    Completion of trial

    Upon completion of the treatment phase, final assessments are conducted to evaluate the overall response to the therapy.

    Participants may be asked to attend follow-up visits to monitor long-term outcomes and gather additional data for the study.

Who can join the trial?

19 criteria

  • Must have breast cancer that is either a primary tumor needing pre-surgical chemotherapy, locally advanced breast cancer, or metastatic breast cancer needing chemotherapy.
  • Must provide written informed consent before joining the study, following national and local rules.
  • Blood test results must meet these requirements:
    • Neutrophils (a type of white blood cell) greater than 1.0 x 109/L
    • Platelets (cells that help with blood clotting) greater than 75 x 109/L
    • Bilirubin (a substance made during the breakdown of red blood cells) less than 20 μmol/L
    • Serum creatinine (a waste product in the blood) less than 1.5 times the upper limit of normal (ULN)
    • Must have resistance to endocrine therapy (hormone therapy), meaning either:
      • The tumor is negative for estrogen and progesterone, or
      • The tumor is positive for estrogen and/or progesterone, but regular hormone therapies have failed or are not suitable according to the doctor.
      • For metastatic disease (cancer that has spread):
        • No prior chemotherapy is allowed for first-line treatment, except for patients with TP53 mutated disease.
        • Previous hormone therapy with or without CDK4/6 inhibitor or mTOR inhibitors is allowed if the disease is hormone receptor positive and HER2 negative.
        • Previous chemotherapy, including alkylating agents or platinum, is allowed if completed more than 12 months before joining the trial.
        • For primary breast cancer:
          • Must have had prior exposure to and lack of response to a taxane regimen.
          • Must have had prior exposure to and lack of response to an anthracycline regimen.
          • The primary tumor or at least one metastatic lesion must be available for biopsy collection when joining the study.
          • Must have measurable breast cancer as documented by clinical or radiographic methods according to RECIST criteria.
          • Must have a WHO performance status of 0-1, indicating the level of daily activity and ability to care for oneself.
          • Must have known tumor status for ER (estrogen receptor), PGR (progesterone receptor), and HER2 (a protein that can affect the growth of cancer cells).
          • Must be over 18 years old.
          • Must have radiology studies for tumor measurements and heart function tests done within 28 days before starting treatment.

Who cannot join the trial?

4 criteria

  • Patients who do not have **breast cancer** cannot participate.
  • Only **female** patients can participate; male patients are excluded.
  • Patients who are not within the specified **age range** cannot participate. The age range is typically defined by the study, so please check if you fall within it.
  • Patients who are part of a **vulnerable population** are excluded. This usually means groups that need special protection, like children or those unable to give consent.
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Investigated drugs

Cyclophosphamide is a type of chemotherapy drug used in this trial to treat patients with advanced breast cancer. It works by slowing or stopping the growth of cancer cells. In this study, cyclophosphamide is given in a dose-dense manner, which means it is administered more frequently than in standard treatment schedules. This approach aims to increase the effectiveness of the treatment by reducing the time cancer cells have to recover between doses. The trial is specifically looking at how well this treatment works in patients whose breast cancer has a mutation in the TP53 gene, as well as in those without this mutation.

What is already known about the treatment

Cyclophosphamide – Cyclophosphamide is administered in a dose-dense form, typically through intravenous infusion, which means it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced breast cancer, particularly in patients with TP53 mutations. The main therapeutic use of cyclophosphamide is to treat various types of cancer, including breast cancer. At the molecular level, cyclophosphamide works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is classified as an alkylating agent, a type of chemotherapy drug that targets rapidly dividing cells.

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 tissues and lymph nodes. The cancer cells can invade surrounding healthy breast tissue and form a mass or lump. Over time, the cancer may metastasize, spreading to other parts of the body. The progression of breast cancer can vary greatly depending on the type and stage of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515135-29-00Protocol codeP53Estimated enrolment63 patientsSponsorHelse Bergen HF

sourced from the EU Clinical Trials Register and site verification

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