Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

COMPRENDO - A PHASE II OPEN LABEL STUDY FOR THE COMPREHENSIVE ANALYSIS OF PREDICTORS OF THE TREATMENT WITH PEMBROLIZUMAB AND OLAPARIB IN PATIENTS WITH UNRESECTABLE OR METASTATIC HER2 NEGATIVE BREAST CANCER AND A DELETERIOUS GERMLINE MUTATION IN BRCA1/2, ATM, BARD1, CHEK2, FANCC, PALB2, RAD51C, RAD51D, SLX4, XRCC2 OR A HOMOLOGOUS RECOMBINATION DEFICIENCY

This research study, called COMPRENDO, is for people in the UK with advanced breast cancer that has spread to other parts of the body or can't be removed by surgery. It is specifically for those whose breast cancer is HER2 negative and who have certain genetic changes in genes like BRCA1/2. These gene changes mean their body might have trouble repairing damaged cells. The study is testing two drugs, pembrolizumab and olaparib, to see how well they work together. Researchers want to find out if this combination can shrink tumours. They will also look at how long people respond to the treatment, how long they live without their cancer getting worse, and any side effects. This is a Phase II study, meaning it aims to further check the safety and how well the treatment works.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut fuer Frauengesundheit GmbH

Enrolment target

Start

28 Nov 2024

patients with unresectable or metastatic HER2 negative breast cancer and a deleterious germline mutation in BRCA 1/2 ATM BARD1 CHEK2 FANCC PALB2 RAD51C RAD51D SLX4 XRCC2 or a homologous recombination deficiency

What is this study about?

This study, named COMPRENDO, is looking into new ways to treat a specific type of advanced breast cancer. This is for breast cancer that has spread to other parts of the body (metastatic) or can't be removed with surgery (unresectable). The cancer also needs to be 'HER2 negative', which means it doesn't have too much of a protein called HER2.

The main focus of this study is on patients who have certain inherited gene changes. These changes are in genes like BRCA1, BRCA2, and others such as ATM or PALB2. These genes are normally involved in repairing damaged cells. When they have a change (mutation), it can affect how the body fixes cell damage, and this is sometimes called 'homologous recombination deficiency'.

Researchers are giving two drugs, pembrolizumab and olaparib, to see how well they work together to treat this type of breast cancer. They want to find out if this combination can shrink the tumours. They will also check how long the treatment keeps the cancer under control, how long patients live, and what side effects might happen. This is a Phase II study, which means it's a step closer to finding new treatments and gathering more information about their safety and effectiveness.

Key takeaways

Targets advanced, HER2 negative breast cancer.
For patients with specific inherited gene changes.
Tests a combination of two drugs: pembrolizumab and olaparib.
Aims to see if the treatment shrinks tumours.
Closely monitors safety and side effects.
Involves regular hospital visits and assessments.

Who may be eligible?

This study is particularly for adults aged 18 and over, and both men and women can take part. To be considered, you must have advanced breast cancer that either can't be removed by surgery or has spread to other parts of the body.

Crucially, your breast cancer must be 'HER2 negative'. This means a specific test on your cancer cells showed low levels of the HER2 protein. You also need to have a specific inherited gene change (called a germline mutation). These are changes in genes like BRCA1/2, ATM, PALB2, and several others involved in how your body repairs cells.

There will also be other health checks and criteria to make sure the treatment is safe for you. Your specialist doctor will be able to tell you if you meet all the requirements for this study.

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 breast cancer that has spread or can't be removed by surgery?
Is your breast cancer HER2 negative?
Have you had a genetic test showing a harmful change in genes like BRCA1/2, ATM, or PALB2?
Are you able to travel to study appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive two drugs, pembrolizumab and olaparib. These drugs will be given to you over a period of time. You will have regular hospital visits for assessments, which will include blood tests, physical examinations, and scans to see how your body is responding to the treatment and to keep an eye on your general health.

These visits will happen from when you start the study until at least 27 weeks later. The full length of your participation will depend on how you respond to the treatment and the study's requirements, but it could involve ongoing checks even after the main treatment phase. You will be closely monitored for any side effects.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to new treatments (pembrolizumab and olaparib) that are not yet widely available for your specific type of breast cancer. These treatments could potentially shrink your tumour or slow its growth. However, like all medications, they can cause side effects, which might be mild or more serious. The research team will carefully monitor you for any side effects throughout the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your future 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
Germany

Common questions

What is HER2 negative breast cancer?

HER2 negative breast cancer means your cancer cells don't have a lot of a protein called HER2. This is important for deciding which treatments might work best.

What does 'unresectable or metastatic' mean?

This means the cancer cannot be completely removed by an operation, or it has spread from where it started to other parts of your body.

What are the drugs pembrolizumab and olaparib?

These are cancer drugs. Pembrolizumab helps your immune system fight cancer, and olaparib targets cancer cells that have trouble repairing themselves.

What are 'gene changes' (mutations) in this study?

These are inherited changes in specific genes like BRCA1/2 that affect how your body repairs damaged cells. Not everyone with breast cancer has these changes.

What is a Phase II study?

A Phase II study aims to further test if a new treatment is safe and effective for a specific condition, after it has shown promise in earlier studies.