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Study on the Effectiveness and Safety of Saruparib and Camizestrant in Adults with Advanced Hormone Receptor-Positive, HER2-Negative 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 is focused on studying treatments for Advanced Breast Cancer, specifically in patients with certain genetic mutations known as BRCA1, BRCA2, or PALB2. The trial will explore the effectiveness and safety of a combination of two medications: Saruparib (also known by its code name AZD5305) and Camizestrant. These medications will be compared to the current standard treatment options, which include a type of medication called CDK4/6 inhibitors combined with Endocrine Therapy or Camizestrant alone. The study aims to determine if the new combination of Saruparib and Camizestrant is more effective in delaying the progression of the disease.

Participants in the study will receive either the new combination treatment or one of the standard treatments, which will be chosen by their doctor. The study will monitor how long the cancer remains stable without getting worse, as well as the overall survival of the participants. The trial will also assess the time it takes for participants to start chemotherapy after the study treatment, the response of the cancer to the treatment, and the duration of any positive response. Additionally, the study will gather information on the side effects experienced by participants, focusing on symptoms like diarrhea and abdominal pain, and how these affect their quality of life.

The trial will also measure the levels of Saruparib and Camizestrant in the blood to better understand how these drugs work in the body. The study is expected to start recruiting participants in late 2024 and will continue until 2030. This research is important for developing new treatment options for people with Advanced Breast Cancer who have specific genetic mutations, and it aims to improve the outcomes and quality of life for these patients.

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 a diagnosis of advanced breast cancer with certain genetic mutations.

    Participants must have adequate organ and marrow function and meet other health requirements.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the combination of saruparib and camizestrant or a physician's choice of CDK4/6 inhibitor plus endocrine therapy or camizestrant.

  3. Step 3

    Treatment administration

    The treatment involves taking medications orally or via intramuscular injection, depending on the assigned group.

    Medications include saruparib, camizestrant, and other options such as exemestane, palbociclib, abemaciclib, fulvestrant, anastrozole, letrozole, and ribociclib.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the progression of the disease and the effectiveness of the treatment.

    Assessments include measuring progression-free survival and overall survival, as well as monitoring for any side effects.

  5. Step 5

    Completion of treatment

    The treatment continues until disease progression or unacceptable side effects occur.

    The study aims to determine the time to chemotherapy and the duration of response to the treatment.

  6. Step 6

    Follow-up

    After completing the treatment, follow-up visits are scheduled to monitor long-term outcomes and any late side effects.

    The study is estimated to conclude by July 18, 2030.

Who can join the trial?

6 criteria

  • Participants must be adult females, either before, during, or after menopause, and adult males.
  • Participants must have a confirmed diagnosis of breast cancer that is positive for hormone receptors (HR-positive) and negative for a protein called HER2.
  • Participants must have advanced breast cancer, which means the cancer has spread locally and cannot be cured with treatment, or it has spread to other parts of the body (metastatic).
  • Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
  • Participants must provide a sample of their tissue that shows a specific type of genetic change called a loss of function mutation in the BRCA1, BRCA2, or PALB2 genes.
  • Participants must have organs and bone marrow that are working well enough to participate in the study.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer other than Advanced Breast Cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are not female or male subjects as required by the study cannot participate.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

  • Saruparib (AZD5305)

    is an experimental medication being studied for its potential to treat advanced breast cancer. It is being tested in combination with other therapies to see if it can help slow down or stop the progression of cancer in patients with specific genetic mutations.

  • Camizestrant

    is a medication used in the treatment of hormone receptor-positive breast cancer. It works by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells. In this trial, it is being used in combination with other treatments to evaluate its effectiveness in managing advanced breast cancer.

  • CDK4/6 Inhibitors

    are a class of drugs used in cancer treatment that work by interfering with the cancer cell cycle, effectively slowing down or stopping the growth of cancer cells. In this study, they are being used as part of the physician's choice treatment to compare their effectiveness with other therapies in treating advanced breast cancer.

What is already known about the treatment

  • Saruparib

    Saruparib is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced breast cancer, particularly in patients with specific genetic mutations such as BRCA1, BRCA2, or PALB2. It is not yet widely available in medical practice as it is still under investigation. The medication works by inhibiting certain enzymes involved in DNA repair, which can help prevent cancer cells from repairing themselves and continuing to grow. Saruparib is classified as a PARP inhibitor, a type of targeted cancer therapy.

  • Camizestrant

    Camizestrant is taken orally and is being evaluated in clinical trials for its potential use in treating advanced breast cancer, especially in hormone receptor-positive, HER2-negative cases. It is not yet approved for general medical use as it is still in the research phase. Camizestrant functions by blocking estrogen receptors, which can slow down or stop the growth of cancer cells that rely on estrogen. It belongs to the class of medications known as selective estrogen receptor degraders (SERDs).

Investigated diseases

Advanced Breast Cancer – This is a stage of breast cancer where the disease has spread beyond the initial site to other parts of the body. It often involves the lymph nodes, bones, liver, lungs, or brain. The progression of advanced breast cancer can vary, with some individuals experiencing rapid spread while others may have a slower progression. Symptoms may include persistent pain, fatigue, and changes in breast appearance or size. The disease can lead to complications depending on the organs affected. Management focuses on controlling the spread and alleviating symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504180-16-00Protocol codeD9722C00001Estimated enrolment500 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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