RecruitingPhase IIInterventional

Is datopotamab deruxtecan plus durvalumab more effective than datopotamab deruxtecan alone at treating patients with metastatic breast cancer?

This research is investigating a new way to treat advanced breast cancer that has spread in the body (metastatic) or is locally advanced. Specifically, it's for patients with a type called PD-L1 negative, triple-negative breast cancer (TNBC), which can be difficult to treat. The study will compare two different treatment approaches: giving a drug called datopotamab deruxtecan on its own, versus giving it alongside another drug called durvalumab. Doctors want to find out if combining these two drugs works better and is safe for patients. This is a Phase II trial, meaning it's an early-stage study to see if the treatment works and what side effects it might have. It's hoped this research will help improve treatment options for this type of breast cancer.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

Queen Mary University of London

Enrolment target

140

Start

31 Jul 2025

Estimated completion

31 Jul 2027

Locally advanced or metastatic PD-L1 negative, triple-negative breast cancer

What is this study about?

This study is being done to explore new and better ways to treat a specific type of breast cancer. It focuses on what doctors call 'PD-L1 negative, triple-negative breast cancer' that has either spread to other parts of the body (metastatic) or is locally advanced. Triple-negative breast cancer (TNBC) is a challenging form of breast cancer because it doesn't respond to common hormone or HER2 treatments. For a certain group of TNBC patients (those who are PD-L1 negative), current standard treatments haven't shown much benefit when combined with immune-boosting drugs.

The main goal of this research is to see if a new combination of medicines can be more effective. The study uses two drugs: datopotamab deruxtecan and durvalumab. Datopotamab deruxtecan is designed to target specific cells in the tumour. Durvalumab is an 'immune checkpoint inhibitor,' which means it helps your body's own immune system fight the cancer more effectively. Early research suggests these two types of drugs might work well together.

By comparing these treatments, the study aims to understand if the combination makes a real difference in controlling the cancer, improving patients' lives, and what side effects might occur. This is an important step towards finding better treatment options for patients who urgently need them.

Key takeaways

This study is for advanced or metastatic PD-L1 negative, triple-negative breast cancer.
It compares one new drug (datopotamab deruxtecan) against a combination of two drugs (datopotamab deruxtecan plus durvalumab).
The goal is to find out if the combination treatment is more effective and safe.
Participation involves random assignment to a treatment group and regular check-ups, scans, and blood tests.
Potential benefits and risks, including side effects, will be discussed in detail by the study team.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for both men and women aged 18 or older.

To join, you must have been diagnosed with a specific type of breast cancer called 'PD-L1 negative, triple-negative breast cancer.' This means your cancer cells don't have certain features that doctors look for. Your cancer must also be considered advanced (meaning it has grown significantly in one area) or metastatic (meaning it has spread to other parts of the body).

You will also need to be well enough to take part, as assessed by the study doctors. They will check your general health, including blood tests and how active you are, to make sure the treatment is suitable 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 old or older?
Do you have advanced or metastatic triple-negative breast cancer?
Has your cancer been identified as 'PD-L1 negative'?
Are you generally well enough to participate in a clinical trial, as decided by your doctor?
Are you willing and able to attend regular appointments and have tests like blood samples and scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a series of check-ups and tests. This helps the doctors understand your health and cancer condition, and ensures you meet all the requirements for the study. These may include blood tests and scans like CT or MRI scans of your chest, tummy, pelvis, and possibly your head. You might also need to provide a sample of your tumour tissue.

Once you’ve completed these initial assessments, you will be randomly assigned to one of two treatment groups, like flipping a coin. One group will receive two study drugs (datopotamab deruxtecan and durvalumab), while the other group will receive only one (datopotamab deruxtecan). Both drugs are given through a drip into a vein. You will continue with this treatment for as long as it is helping you, and you are not experiencing severe side effects, or until you choose to stop.

Throughout the study, you'll have regular visits to the clinic for treatments, check-ups, blood tests, and scans to monitor how the treatment is working and to keep an eye on any side effects. The study aims to follow patients from May 2025 until January 2030, but your individual participation length will depend on your treatment response and how long you choose to continue.

Potential risks and benefits

Participating in this study might offer a chance to receive a new treatment that could potentially be more effective for your specific type of breast cancer than existing options. However, because it's a research study, we cannot guarantee that you will personally benefit from the treatment. There's also the risk of side effects from the study drugs, which will be carefully monitored by the study team. They will discuss all known and potential side effects with you, and any problems you experience will be treated. You will have regular check-ups, and the study team is available to answer any questions or concerns you might have. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

St Bartholomews Hospital
City only
London, England
Velindre Cancer Centre
Approximate
Cardiff, Wales
University Hospital Southampton
City only
Southampton, England
Addenbrookes Hospital
City only
Cambridge, England
Royal Cornwall Hospital
City only
Truro, England
University Hospital (coventry)
Unverified
Coventry, England
Musgrove Park Hospital
Unverified
Taunton, England

Common questions

What is 'triple-negative breast cancer'?

Triple-negative breast cancer (TNBC) is a type of breast cancer that doesn't have specific features (receptors for oestrogen, progesterone, or HER2 protein) that are often targeted by other breast cancer treatments. This makes it more challenging to treat, and new options are badly needed.

What does 'PD-L1 negative' mean?

PD-L1 is a protein that can stop the immune system from attacking cancer cells. 'PD-L1 negative' means your cancer cells don't have enough of this protein for certain immune-boosting drugs to work effectively on their own. This study is for people with this specific type of TNBC.

What is a 'Phase II' clinical trial?

A Phase II trial is an early stage of research. It means doctors are testing if a new treatment works, what common side effects it might have, and how it affects the body. It follows Phase I trials, which mainly check for safety.

How long will the study treatment last?

You will receive the study treatment for as long as it is helping your cancer, you are not experiencing unbearable side effects, or until you decide you want to stop. The overall study will run until January 2030.

Will I know which treatment I am receiving?

Yes, this is an 'open-label' study, which means both you and your doctor will know which treatment group you are in (either one drug or the combination of two drugs).

How to find out more

DIAMOND Coordinating team -

bci-diamond@qmul.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.