Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Predicting olaparib sensitivity in patients with unresectable locally advanced/metastatic HER2-negative breast cancer with BRCA1, BRCA2, PALB2, RAD51C or RAD51D mutations or RAD51-foci low test: RADIOLA TRIAL

This study, called RADIOLA, is looking at a medicine called Lynparza (which comes as tablets) for people with advanced HER2-negative breast cancer that has spread or can't be removed by surgery. This includes both triple-negative breast cancer and hormone-positive breast cancer that hasn't responded to other treatments. Researchers want to see how effective Lynparza is at shrinking tumours in people who have certain genetic changes (in genes like BRCA1, BRCA2, PALB2, RAD51C, or RAD51D, or a specific test called 'RAD51-foci low'). By understanding this, the study aims to find out if Lynparza could be a helpful treatment for these particular groups of patients, offering a new possible way to fight their cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Solti Group

Enrolment target

Start

03 Jun 2024

What is this study about?

This study, known as the RADIOLA Trial, is exploring a new way to treat certain types of advanced breast cancer. Specifically, it's for people with HER2-negative breast cancer that has spread to other parts of the body (metastatic) or cannot be removed with surgery (locally advanced). This includes two main groups: those with triple-negative breast cancer, and those with hormone receptor-positive breast cancer that hasn't responded to previous hormone therapy with CDK4/6 inhibitors.

The main goal of the study is to see how well a drug called Lynparza works in these patients. Lynparza is a tablet medicine already used for some types of cancer. The researchers are especially interested in whether Lynparza is effective for patients who have specific changes in their genes, such as BRCA1, BRCA2, PALB2, RAD51C, or RAD51D, or who have a particular test result showing 'RAD51-foci low' in their tumour cells. These gene changes might make cancer cells more sensitive to Lynparza.

By carefully watching how patients respond to Lynparza, the study aims to understand if this medicine can shrink tumours in these specific groups of people. This understanding is very important because it could help doctors choose the best treatments for patients based on the unique features of their cancer. This is a "Phase II" study, which means it builds on earlier research and aims to confirm how well a treatment works and its safety in a larger group of patients. The results will help guide future treatment decisions.

Key takeaways

The study is testing Lynparza for advanced HER2-negative breast cancer.
It's for people with specific gene changes (like BRCA1/2) or a 'RAD51-foci low' test.
The main goal is to see how well Lynparza shrinks tumours in these patients.
It's a Phase II study, meaning it checks effectiveness and safety.
Participation involves taking tablets and having regular check-ups and scans.

Who may be eligible?

To be considered for this study, you must be an adult (18 years or older), male or female, and have been diagnosed with advanced breast cancer that is HER2-negative.

Specifically, your breast cancer needs to be either triple-negative (meaning it doesn't have hormone receptors or HER2 protein) or hormone receptor-positive and HER2-negative, but has stopped responding to hormone therapy combined with CDK4/6 inhibitor treatment.

Also, your breast cancer must have certain genetic changes or a specific test result. These include changes in genes like BRCA1, BRCA2, PALB2, RAD51C, or RAD51D, or your tumour cells must show a 'RAD51-foci low' result. These are important for the study as they might predict how well Lynparza works.

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 old or older?
Do you have HER2-negative advanced breast cancer (either triple-negative or hormone-positive that hasn't responded to past treatment)?
Does your cancer have specific gene changes (like BRCA1, BRCA2, PALB2, RAD51C, or RAD51D mutations)?
Or, does your tumour have a 'RAD51-foci low' test result?

Answer every question to see your result.

What does participation involve?

If you join this study, you will take Lynparza tablets, either 150 mg or 100 mg, as instructed by the study team. You will have regular visits to the clinic for check-ups, which will include physical exams and possibly blood tests and scans (like CT or MRI scans) to see how your tumour is responding. These tests will help the doctors measure if your tumour is shrinking or staying the same. The study will also track any side effects you might experience. The total duration of your participation will depend on how you respond to the treatment and the study's monitoring schedule, which can involve regular follow-up for several months or longer.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment like Lynparza before it's widely available, which could help manage your cancer. However, there are also potential risks, including side effects from the medication, which will be carefully monitored. You will be given detailed information about these. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is HER2-negative breast cancer?

HER2-negative breast cancer means your cancer cells do not have a lot of a protein called HER2. This is important because it means certain treatments that target HER2 won't work for you.

What are BRCA1, BRCA2, and other gene mutations?

BRCA1, BRCA2, PALB2, RAD51C, and RAD51D are genes that help repair damaged DNA in your cells. Changes (mutations) in these genes can sometimes increase the risk of certain cancers, including breast cancer, and might make the cancer respond differently to treatments like Lynparza.

What is Lynparza?

Lynparza is a tablet medicine that works by blocking certain proteins in cancer cells, making it harder for them to repair themselves and grow. It's already approved for some cancers and is being tested here for its use in specific breast cancers.

What does 'unresectable locally advanced or metastatic' mean?

This means the breast cancer has either grown too much to be completely removed by surgery (locally advanced) or has spread to other parts of your body (metastatic).

Could this study help me even if my cancer doesn't have these specific gene changes?

This study is specifically designed for people with these particular gene changes or test results because Lynparza is thought to work best in these situations. If you don't have these, your doctor might discuss other treatment options with you instead.