Active not recruitingPHASE2INTERVENTIONAL

Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer

This research is investigating new treatments for early-stage breast cancer that has a BRCA gene change and is HER2-negative. The study focuses on two medicines: olaparib, which stops cancer cells from repairing themselves, and durvalumab, an immunotherapy that helps your immune system fight cancer. Participants will receive either olaparib alone or olaparib combined with durvalumab before surgery. These treatments are being tested to see if they can effectively shrink tumours and improve outcomes, potentially reducing the need for traditional chemotherapy in some patients. The study aims to understand how well these treatments work, their safety, and how they impact the disease.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AstraZeneca

Enrolment target

Start

07 Nov 2022

Estimated completion

31 Dec 2026

Breast Cancer

What is this study about?

This study is designed to learn more about new ways to treat a specific type of breast cancer. It's for people who have breast cancer with a change in their BRCA1 or BRCA2 gene, and whose cancer is HER2-negative. This is important because having a BRCA gene change can sometimes mean the cancer behaves differently, and we need specific treatments for it.

The study looks at two different medicines. One is called olaparib. Olaparib works by stopping cancer cells from fixing themselves, which can then lead to these cells dying. The other medicine is durvalumab, which is an immunotherapy. This type of medicine helps your body's own immune system to recognise and attack cancer cells. These medicines are not yet approved for treating breast cancer in all situations, so this study helps doctors understand if they are safe and effective for this specific type of breast cancer.

The main goal is to see if these treatments, given before surgery, can work well to shrink the cancer. This could potentially improve the chances of long-term success and might even mean that some people need less traditional chemotherapy later on. The study is also helping us learn more about breast cancer and any related health issues, so we can keep improving care for patients.

Key takeaways

This study is for a specific type of breast cancer with a BRCA gene change.
It tests new medicines (olaparib and durvalumab) before surgery.
The goal is to find better and potentially less harsh treatments.
Participation involves regular check-ups and monitoring.
Treatment combinations are experimental for breast cancer.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and capable of giving your permission to take part. Researchers are looking for people who have been recently diagnosed with breast cancer that hasn't spread and has specific features: it must be HER2-negative, and either ER-negative or ER-low. A key requirement is that your cancer must also have a specific change in the BRCA1 or BRCA2 gene.

Your tumour size and whether or not it has spread to nearby lymph nodes are also important factors. The study is looking for cancers that fall into certain size and spread categories (like T1b-c/N0, T1/N1, or T2/N0). You also need to be in good general health, which doctors describe using a score called ECOG performance status 0 or 1, and have healthy organ function.

There are also some reasons why you might not be able to join. These include having other serious health conditions, uncontrolled infections, or certain heart problems. The research team will review all your medical information carefully to make sure the study is right for you.

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 a BRCA1 or BRCA2 gene change in your cancer?
Is your breast cancer HER2-negative and either ER-negative or ER-low?
Has your breast cancer not spread to other parts of your body?
Are you generally in good health and able to manage daily activities?
Are you willing to have a biopsy before treatment starts?

Answer every question to see your result.

What does participation involve?

If you join this study, you will either receive only olaparib or a combination of olaparib and durvalumab. These treatments will be given before you have surgery for your breast cancer. You will have regular appointments for check-ups, blood tests, and scans to see how you are responding to the medication and to monitor your general health. You will also need to have a small tissue sample (biopsy) taken from your tumour before starting treatment, and any leftover tissue from your diagnostic biopsy might be used for research. The exact number of visits and the total duration in the study will be explained in detail by the study team, but it will involve managing your medication and attending follow-up checks. You can stop participating at any time.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving new treatments that could be more effective for your specific type of breast cancer than standard options, potentially improving your outcome. However, these treatments are still being studied for breast cancer, meaning their full effects are not completely known. You might experience side effects from the medications, which the study team will monitor closely. There is also the potential for unknown risks. All known risks and potential side effects will be explained to you in detail. Remember, deciding whether to participate is entirely your choice, and you are free to withdraw from the study at any time without affecting your future medical care.

Locations (37)

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

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Greeley, United States
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Loveland, United States
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Boston, United States
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Portland, United States
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Philadelphia, United States
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Melbourne, Australia
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Rankweil, Austria
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Salzburg, Austria
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Brussels, Belgium
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Liège, Belgium
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Augsburg, by, Germany
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Cologne, Germany

Common questions

What is a BRCA gene change?

BRCA is a gene that normally helps repair damaged cells. A change in this gene can sometimes increase the risk of certain cancers, including breast cancer, and can make specific treatments more effective.

What is 'HER2-negative' breast cancer?

HER2-negative means that the cancer cells don't have a lot of a protein called HER2. This is important because it tells doctors which treatments, like those targeting HER2, won't work for your cancer.

What does 'neoadjuvant' mean?

Neoadjuvant treatment means you receive medication like chemotherapy, immunotherapy, or targeted therapy before surgery. The aim is often to shrink the tumour, making surgery easier or more effective.

Are the treatments in this study approved for everyone?

Olaparib is approved for some forms of breast cancer, but the use of durvalumab and the combination of both drugs for breast cancer are still experimental and are not yet approved outside of research studies like this one.

Will I still need surgery if I join the study?

Yes, this study gives treatment *before* surgery. The aim is to see if the medications can shrink the cancer effectively beforehand, but surgery is still planned as part of your treatment plan.