A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination with Other Anti-cancer Agents in Patients with Metastatic HER2-low Breast Cancer (DESTINY-Breast08)
This research study is for people with advanced breast cancer that has begun to spread and is classified as 'HER2-low'. Doctors are testing a new drug called Trastuzumab Deruxtecan (T-DXd) alongside other cancer treatments. The main goals are to check if these new drug combinations are safe and well-tolerated. Researchers also want to understand how the drugs act in the body and if they can reduce the size of tumours. This is an early-stage study, meaning it's one of the first times these specific combinations are being tested in people. It builds on earlier research to find better ways to treat this type of breast cancer.
At a glance
What is this study about?
This study, called DESTINY-Breast08, is exploring new ways to treat breast cancer that has spread to other parts of the body (this is called metastatic breast cancer). Specifically, it's looking at a type of breast cancer where there's a low amount of a protein called HER2. Even though this type of cancer has some HER2, it's not enough to be treated with standard HER2-targeted drugs, so new treatment options are really important.
The main treatment being studied is a drug called Trastuzumab Deruxtecan (T-DXd). Researchers are giving this drug along with other established cancer medicines like TRUQAP, Faslodex, PACLITAXEL, IMFINZI, and Capecitabine. The aim is to see if these combinations work better together than alone and if they are safe for patients. This is an 'open-label' study, which means both you and your study doctor will know which medicines you are receiving.
This study will carefully monitor patients for any side effects and how their bodies handle the new drug combinations. It also aims to see if the treatments can shrink tumours or stop them from growing for longer periods. Early-phase studies like this are crucial steps in finding new and more effective treatments for cancer patients in the future.
Key takeaways
- This study explores new treatments for advanced 'HER2-low' breast cancer.
- It tests combinations of a new drug (T-DXd) with existing cancer medicines.
- Main goals are to check safety, how drugs work, and tumour response.
- Open to adults aged 18 and older, both men and women.
- Participation involves regular clinic visits, tests, and medical monitoring.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. You must have metastatic breast cancer, meaning your cancer has spread to other parts of your body, and it needs to be the 'HER2-low' type. Your medical team will do tests to confirm this specific type of breast cancer.
You will also need to meet other health requirements to make sure it's safe for you to participate. This includes having generally good health for someone with cancer, and your doctor will check your organ function (like your heart, liver, and kidneys) to ensure they are working well enough for you to receive the study medications.
Your study doctor will discuss all the detailed requirements with you to see if this study is a good fit for your situation. They will make sure you understand everything before you make any decisions.
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 at least 18 years old?
- Do you have breast cancer that has spread to other parts of your body?
- Has your doctor confirmed that your breast cancer is 'HER2-low'?
- Are you generally well enough to start a new treatment?
- Are you able to attend regular clinic appointments and undergo necessary tests?
What does participation involve?
If you decide to join this study, you will receive a combination of medicines given either as tablets or injections, depending on the specific drugs. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. The exact number of visits and tests will depend on which part of the study you are in.
During your time in the study, doctors will keep a close eye on any reactions you might have, how your body processes the medicines, and how your tumour is affected. The study is designed to continue for a period, with follow-up appointments even after you stop taking the study medication, to track your health and any long-term effects. Your study team will explain the full schedule of appointments and what each one involves.
Potential risks and benefits
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Common questions
What does 'metastatic breast cancer' mean?
It means the breast cancer has spread from your breast to other parts of your body.
What does 'HER2-low' mean for breast cancer?
It refers to a type of breast cancer that has a small amount of a protein called HER2, but not enough to be treated with standard HER2-targeting drugs.
Are the study drugs new?
Some of the combinations in this study are new, but some of the individual drugs are already approved for cancer treatment.
What is the main goal of this study?
The main goal is to find out if new drug combinations are safe, how they work, and if they can shrink tumours in people with HER2-low metastatic breast cancer.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, so you and your doctor will know which study medicines you are receiving.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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