Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Safety and Effectiveness of Olaparib, Ceralasertib, and AZD1775 for Patients with Metastatic Triple Negative Breast Cancer

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying a type of breast cancer known as Triple Negative Breast Cancer, which is a form of cancer that does not have any of the three common receptors known to fuel most breast cancer growth. The study is investigating the effectiveness and safety of a treatment using a combination of medications. The medications being studied include Olaparib, which is already used in cancer treatment, and Ceralasertib, also known by its code name AZD6738. These medications are being tested both in combination and separately to see how well they work in treating this type of cancer.

The purpose of the study is to assess how these treatments can help patients with metastatic triple negative breast cancer, which means the cancer has spread to other parts of the body. The study will compare the effects of using Olaparib alone versus using it in combination with Ceralasertib. Participants will take these medications in the form of film-coated tablets, which are taken orally. The study will monitor the progression of the disease and any side effects that may occur during the treatment period.

Participants in the study will be randomly assigned to receive either the combination of medications or Olaparib alone. The study will take place over a period of time, with regular assessments to track the cancer's response to the treatment. The goal is to determine which treatment option is more effective in managing the disease and improving the quality of life for patients with this challenging form of breast 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 study

    Upon joining the study, informed consent is required. This means understanding the study details and agreeing to participate.

    Eligibility is confirmed based on specific criteria, such as age, cancer progression, and previous treatments.

  2. Step 2

    Randomization

    Participants are randomly assigned to different treatment groups. This ensures that the study results are unbiased.

  3. Step 3

    Treatment phase

    Participants receive either olaparib alone or in combination with ceralasertib.

    Olaparib is administered as film-coated tablets, available in 100 mg and 150 mg doses, taken orally.

    Ceralasertib is also administered as film-coated tablets, taken orally.

    The dosage and frequency of administration are determined by the study protocol and may vary between participants.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the treatment's effectiveness and any side effects.

    This includes imaging tests like CT or MRI scans to measure tumor size and progression.

    Blood tests are performed to check organ function and drug levels in the plasma.

  5. Step 5

    End of treatment

    The treatment phase continues until the study's end date or until the participant's condition changes.

    Participants may continue to be monitored for overall survival and any long-term effects.

Who can join the trial?

12 criteria

  • Provide informed consent before any study-specific procedures. This means you agree to participate after understanding the study details.
  • Be postmenopausal or have proof of not being able to have children if you are a woman who could potentially have children. This includes following birth control rules for you and your partner.
  • Be willing to follow the study's rules and requirements.
  • Have a life expectancy of at least 16 weeks.
  • Be a male or female who is 18 years of age or older.
  • Have cancer that is getting worse at the time you join the study.
  • Have a confirmed diagnosis of Triple Negative Breast Cancer (TNBC) that has spread to other parts of the body and is HER2 negative according to specific guidelines.
  • Have received at least one and no more than two previous treatments for cancer that has spread, including specific drugs like anthracyclines (e.g., doxorubicin, epirubicin) and/or taxanes (e.g., paclitaxel, docetaxel), unless you cannot take them.
  • Have a confirmed presence or absence of a specific HRR mutation in your tumor tissue, as determined by a specific test.
  • Have at least one measurable tumor that can be accurately checked at the start of the study using a CT scan or MRI if a CT scan is not suitable, and can be checked again during the study.
  • Have normal function of your organs and bone marrow, as measured within 28 days before being randomly assigned to a treatment group.
  • Have an ECOG Performance Status of 0-1 within 28 days of being randomly assigned. This is a scale that measures your ability to perform daily activities.

Who cannot join the trial?

5 criteria

  • Patients with medical conditions other than Triple Negative Breast Cancer cannot participate. This type of cancer does not have certain receptors that are commonly found in breast cancer.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of participants.
  • Patients who are not female or male cannot participate. The study includes both genders.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children or the elderly.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Olaparib

    is a medication used in this trial to treat metastatic triple-negative breast cancer. It works by blocking a specific enzyme involved in repairing damaged DNA in cancer cells, which can help to stop the growth of cancer.

  • Ceralasertib

    is being tested in combination with olaparib. It is designed to enhance the effects of olaparib by further inhibiting the cancer cells' ability to repair DNA damage, potentially leading to more effective treatment outcomes.

  • AZD1775

    is another medication being studied in combination with olaparib. It aims to disrupt the cancer cells' repair mechanisms, similar to ceralasertib, and is being evaluated for its potential to improve the effectiveness of olaparib in treating the cancer.

What is already known about the treatment

  • Olaparib

    Olaparib is administered orally in the form of tablets. It is currently used in clinical settings and extensively discussed in medical literature for its role in treating certain types of cancer. The main therapeutic indication for olaparib is the treatment of metastatic triple-negative breast cancer, particularly in patients with specific genetic alterations. At the molecular level, olaparib works by inhibiting the enzyme PARP, which is involved in DNA repair, thereby preventing cancer cells from repairing themselves and leading to their death. It is classified as a PARP inhibitor in pharmacology.

  • Ceralasertib

    Ceralasertib is administered orally and is being studied in clinical trials for its potential use in cancer treatment. It is not yet widely used in standard medical practice but is being investigated for its effectiveness in combination with other drugs. The main therapeutic indication being explored is its use in treating metastatic triple-negative breast cancer. Ceralasertib works by inhibiting the ATR protein, which plays a role in DNA damage response, thereby enhancing the effects of other cancer therapies. It is classified as an ATR inhibitor.

  • AZD1775

    AZD1775 is taken orally and is currently under investigation in clinical trials for its potential benefits in cancer therapy. It is not yet approved for general medical use but is being evaluated for its efficacy in combination with other treatments. The primary therapeutic indication being studied is its use in metastatic triple-negative breast cancer. AZD1775 functions by inhibiting the WEE1 kinase, a protein that regulates cell division, thus making cancer cells more susceptible to damage from other treatments. It is classified as a WEE1 inhibitor.

Investigated diseases

Triple Negative Breast Cancer – This is a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It is considered more aggressive and difficult to treat than other types of breast cancer. The cancer cells in triple negative breast cancer do not respond to hormonal therapy medicines or medicines that target HER2 protein receptors. It tends to grow and spread more quickly than other types of breast cancer. This type of cancer is more likely to affect younger women and those with a BRCA1 gene mutation. It is often diagnosed at a later stage, which can make it more challenging to manage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514205-60-00Protocol codeD5336C00001Estimated enrolment3 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.