Active not recruitingPHASE2INTERVENTIONAL

To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.

This study, called a Phase 2 trial, is investigating advanced triple-negative breast cancer (TNBC) that has spread to other parts of the body (metastatic). Researchers are comparing Olaparib, a medication that targets DNA repair, on its own with Olaparib combined with another drug called Ceralasertib. The goal is to see which treatment works best and is safest for patients whose cancer has specific genetic changes in its DNA repair system. They initially also looked at a third combination, Olaparib with Adavosertib, but this arm of the study was stopped. Participants in the study are carefully monitored, and their treatment is tailored based on the genetic makeup of their cancer, helping to advance our understanding of personalised cancer care.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AstraZeneca

Enrolment target

273

Start

07 Mar 2018

Estimated completion

04 Sep 2026

Metastatic Triple Negative Breast Cancer

What is this study about?

This research study is focused on a type of breast cancer known as triple-negative breast cancer (TNBC). This can be a more aggressive form of breast cancer, which often doesn't respond to standard hormone or HER2-targeted therapies. The study is particularly interested in advanced TNBC, meaning it has spread beyond the original site.

The main aim of this study is to test a drug called Olaparib, both on its own and in combination with another experimental drug called Ceralasertib. These drugs work by targeting pathways involved in repairing DNA within cancer cells. The hope is that by interfering with these repair mechanisms, the cancer cells will be more easily destroyed, leading to more effective treatment. Researchers are looking at how well these treatments work (their effectiveness) and if there are any side effects (their safety). This kind of study helps us learn if new treatments or combinations of existing treatments might be better than what's currently available.

An important part of this study is understanding the genetic make-up of each patient's cancer. Before joining the main study, patients undergo a screening to check for specific changes (mutations) in genes involved in a process called homologous recombination repair (HRR). This allows researchers to group patients based on their specific cancer characteristics, to see if certain treatments work better for particular genetic profiles. This personalised approach is crucial for developing targeted therapies that are more likely to benefit individual patients. While a third combination (Olaparib with Adavosertib) was initially part of the study, this treatment arm was discontinued, with patients offered the opportunity to continue on Olaparib alone.

Key takeaways

This study is for advanced triple-negative breast cancer that has spread.
It compares Olaparib alone with Olaparib plus Ceralasertib.
Treatment decisions are influenced by the genetic makeup of your cancer.
You will be closely monitored for effectiveness and side effects.
Participation involves regular hospital visits, oral medication, and scans.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, you must be an adult (18 years or older) with triple-negative breast cancer that has spread to other parts of your body. Your cancer must be confirmed as HER2-negative. You should have already received at least one, but no more than two, previous chemotherapy treatments for your advanced cancer. It's also important that your general health is good, with normal organ and blood test results, and you must be able to move around and perform daily activities with little to no difficulty.

A key requirement is that your cancer cells will be tested for specific genetic changes in their DNA repair pathways. This helps the researchers place you in the right group for the study. You'll also need to have at least one cancerous area that can be easily measured and tracked with scans like CT or MRI.

There are also some reasons why you might not be able to join. For example, if you've recently had chemotherapy, radiation, or other targeted cancer treatments. If you've had more than two prior lines of chemotherapy for advanced disease, or if you have certain other serious medical conditions, you might not be eligible. Your study doctor will discuss all of these points with you in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have triple-negative breast cancer that has spread?
Have you had 1 or 2 prior chemotherapy treatments for your advanced cancer?
Are you generally well and able to manage daily activities?
Are you willing to have your cancer tissue tested for specific genetic changes?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step is an initial screening to check for specific genetic changes in your cancer cells (called HRR mutations). This involves providing a tumour sample. Once these results are available and if you meet all other criteria, you'll be asked if you'd like to continue with the main part of the study. You can take up to 28 days to make this decision after your screening results are in.

If you join the main study, you will be randomly assigned to one of two treatment groups: either Olaparib on its own, or Olaparib combined with Ceralasertib. You will take tablets for these medications continuously in repeating cycles, typically lasting 28 days. Olaparib is taken twice a day, and Ceralasertib is taken once a day for the first 7 days of each 28-day cycle. You will have regular hospital visits for blood tests, scans (like CT or MRI), and check-ups to see how you are responding to the treatment and to manage any side effects. The total duration of your participation will depend on how you respond to the treatment, but you will be monitored closely throughout.

Potential risks and benefits

Taking part in this study could potentially offer you access to new treatments for triple-negative breast cancer that are not yet widely available. The combination of drugs being tested might be more effective than Olaparib alone for some patients. However, like all medications, these drugs can cause side effects. These could range from mild to more serious, and your study doctor and nurses will monitor you very closely to manage any side effects you experience. It's important to remember that there's no guarantee the treatment will work for you, and new treatments always carry unknown risks. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (141)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Birmingham, United States
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Anchorage, United States
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Gilbert, United States
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Aurora, United States
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New Haven, United States
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Chicago, United States
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Munster, United States
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Hazard, United States
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Louisville, United States
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Towson, United States
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Brick, United States
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East Setauket, United States

Common questions

What is 'triple-negative breast cancer'?

Triple-negative breast cancer is a type that doesn't have the three markers (oestrogen receptors, progesterone receptors, and HER2 protein) that other breast cancers often have, making it harder to treat with targeted hormone therapies.

What does 'metastatic' mean?

Metastatic means the cancer has spread from where it started to other parts of your body, such as the bones, lungs, or liver.

What is Olaparib and how does it work?

Olaparib is a targeted drug that blocks a protein involved in repairing damaged DNA in cancer cells, which can make these cells more likely to die. It's often used in cancers with specific genetic faults.

Will I know which treatment I'm receiving?

Yes, this is an 'open-label' study, meaning both you and your study team will know which treatment you are receiving (either Olaparib alone or Olaparib with Ceralasertib).

What is 'Phase 2' in a clinical trial?

Phase 2 studies mainly focus on whether a new treatment works effectively against the cancer and to learn more about its safety and side effects, usually involving a larger group of patients than earlier phases.