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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 study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Hm Sanchinarro Madrid Spain

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Hospital San Pedro De Alcantara Caceres Spain
Ikazia Ziekenhuis Rotterdam The Netherlands
Zachodniopomorskie Centrum Onkologii Szczecin Poland
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Fvueinzbd Pndc Lh Iurjzlrhzlpuc Biplephid Dos Hwcjzqvw Uqtuoaaeamuej Li Prz Madrid Spain
Hhbnkshk Vsyu dlrozslc Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
16.06.2021
Poland Poland
Not recruiting
16.06.2021
Spain Spain
Not recruiting
16.06.2021
The Netherlands The Netherlands
Not recruiting
16.06.2021

Trial locations

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.

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 ID:
2023-504454-35-00
Protocol code:
213831
NCT ID:
NCT04915755
Trial Phase:
Therapeutic confirmatory (Phase III)

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