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Study on Niraparib for Patients with HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer with Molecular Disease Detected by ctDNA

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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 a medication called niraparib in individuals with a specific type of breast cancer. The study involves participants who have either HER2-negative breast cancer with a mutation in the BRCA gene or triple-negative breast cancer. These types of breast cancer are identified by the presence of certain genetic markers in the blood, known as circulating tumor DNA (ctDNA), after the completion of standard treatments like surgery and chemotherapy.

The purpose of the study is to compare the safety and effectiveness of niraparib with a placebo. Participants will be randomly assigned to receive either the medication or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. The study will monitor the safety of niraparib by observing any side effects or changes in health status. The trial will also explore how well the medication works in preventing the return of cancer.

Participants will take the medication in the form of tablets by mouth. The study will last for a period of time, during which regular check-ups and tests will be conducted to ensure the safety and well-being of the participants. The results of this study will help determine if niraparib is a safe and effective treatment option for these specific types of breast cancer.

The research process

The trial runs in 6 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, eligibility is confirmed based on specific criteria, including age, health status, and previous treatments.

    Participants must have completed prior standard therapy for breast cancer, including surgery and chemotherapy, if indicated.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate health status, including organ and bone marrow function.

    A sample is collected to measure circulating tumor DNA (ctDNA) levels.

  3. Step 3

    Randomization

    Participants are randomly assigned to receive either niraparib or a placebo.

    The study is double-blinded, meaning neither the participant nor the researchers know which treatment is being administered.

  4. Step 4

    Treatment administration

    Participants take the assigned treatment orally in the form of tablets.

    The dosage and frequency are determined by the study protocol and are monitored throughout the trial.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess the safety and tolerability of the treatment.

    Participants undergo periodic evaluations, including laboratory tests and assessments of vital signs.

  6. Step 6

    Completion of treatment

    The treatment period concludes as per the study timeline.

    Participants may be required to attend follow-up visits to monitor long-term effects and gather additional data.

Who can join the trial?

14 criteria

  • Must have **Stage I-III breast cancer**. This means the cancer is in an early to moderately advanced stage.
  • Must have had surgery to remove the primary tumor, and the cancer must be either **triple-negative breast cancer (TNBC)** or **hormone receptor-positive (HR+) and HER2-negative** with a specific genetic mutation called **BRCA mutation**.
  • Must be able to swallow and keep down the study medication.
  • Female participants must not be pregnant or breastfeeding. If they can have children, they must use a highly effective birth control method during the study and for 180 days after the last dose. They must also have a negative pregnancy test before starting the study.
  • Male participants must agree to avoid fathering a child during the study and for 90 days after the last dose. They must use a condom and should consider their partner using effective birth control.
  • Must understand the study and agree to participate by signing a consent form.
  • Must have completed previous standard cancer treatments, such as chemotherapy, surgery, and radiation, if needed.
  • If the participant has HR+ breast cancer, they must be on a stable hormone therapy for at least 3 months before joining the study.
  • Must have detectable levels of **circulating tumor DNA (ctDNA)**, which is a type of genetic material from the tumor found in the blood.
  • Must provide a sample of the original tumor tissue for testing.
  • Must have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • Must be at least 18 years old.
  • Must have adequate organ and bone marrow function, which includes having enough healthy blood cells and proper kidney and liver function.
  • If there are side effects from previous cancer treatments, they must have improved to a mild level, except for certain conditions like mild nerve damage or hair loss.

Who cannot join the trial?

8 criteria

  • Participants with other types of cancer besides breast cancer cannot join the study.
  • Individuals who have not completed their main cancer treatments, such as surgery, chemotherapy, or radiation therapy, are not eligible.
  • People who do not have specific genetic changes related to breast cancer, like the BRCA mutation, are excluded. The BRCA mutation is a change in a gene that can increase the risk of breast cancer.
  • Participants with breast cancer that is positive for HER2 are not allowed. HER2 is a protein that can affect the growth of cancer cells.
  • Individuals who do not have detectable levels of circulating tumor DNA (ctDNA) in their blood are not eligible. ctDNA is a small amount of DNA from cancer cells that can be found in the blood.
  • People who are not in the age range specified for the study cannot participate.
  • Participants who are not part of the specified gender groups for the study are excluded.
  • Individuals who are considered part of a vulnerable population, which means they might need special protection or care, are not eligible.
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Investigated drugs

Niraparib is a medication being studied for its effectiveness and safety in treating certain types of breast cancer. It is specifically being tested in participants who have HER2-negative breast cancer with BRCA mutations or triple-negative breast cancer. The study focuses on patients who have completed their main cancer treatments but still have signs of cancer at the molecular level, detected through circulating tumor DNA. The main goal is to assess how safe and tolerable niraparib is for these patients.

What is already known about the treatment

Niraparib – Niraparib is administered orally in the form of capsules. It is currently being studied in clinical trials for its safety and tolerability in treating certain types of breast cancer, specifically HER2-negative BRCA-mutated or triple-negative breast cancer. The main therapeutic indication is for patients with these specific breast cancer types who have molecular disease indicated by circulating tumor DNA after completing standard therapies. At the molecular level, niraparib works by inhibiting the enzyme poly (ADP-ribose) polymerase (PARP), which helps repair DNA damage in cells. By blocking this enzyme, niraparib prevents cancer cells from repairing themselves, leading to their death. It is classified as a PARP inhibitor in pharmacology.

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. It can begin in different parts of the breast, such as the ducts or lobules. The disease progresses as the cancer cells invade nearby tissues and can spread to other parts of the body through the blood and lymph systems. Breast cancer is categorized by the presence or absence of certain receptors, such as hormone receptors and the human epidermal growth factor receptor 2 (HER2). Some types, like triple-negative breast cancer, lack these receptors, making them more challenging to treat. The progression and characteristics of breast cancer can vary widely among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504454-35-00Protocol code213831Estimated enrolment494 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

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