DESTINY Breast Respond HER2-low Europe
This study is gathering information on a medicine called Trastuzumab deruxtecan (T-DXd). It's for adults with breast cancer that has spread or can't be removed by surgery, and where the cancer cells show low levels of a protein called HER2. Patients taking part have usually had chemotherapy before. The study will track how patients use T-DXd in the real world, how effective it is for them, what their experience is like, and any side effects they might have. It will also collect similar information for other standard chemotherapy treatments. Importantly, no new medicine is given as part of this study; it simply observes how doctors already use these treatments.
At a glance
What is this study about?
This study, called "DESTINY Breast Respond HER2-low Europe," is trying to learn more about a specific kind of breast cancer treatment. If you have breast cancer that has spread to other parts of your body (metastatic breast cancer) or can't be removed by surgery (unresectable), and your cancer cells have a low amount of a protein called HER2, this study might be relevant. It focuses on a medicine called Trastuzumab deruxtecan, often shortened to T-DXd.
Doctors use T-DXd for patients who have already had chemotherapy for their advanced breast cancer, or if their cancer came back within six months after finishing chemotherapy given to prevent it from returning. This study isn't testing a new drug or giving out medicine. Instead, it’s looking at how doctors are already using T-DXd in their clinics, following the approved guidelines. It wants to see who gets the medicine, how it's given, how well it works, and what side effects people experience.
It's important to understand that this is a 'non-interventional' study. This means you won't be given any experimental medicine. Instead, the study will simply collect information about the treatment you're already receiving from your doctor, whether that's T-DXd or other standard chemotherapy medicines. This helps researchers understand how these treatments work in everyday clinical practice for people living with HER2-low breast cancer.
Key takeaways
- The study focuses on understanding how Trastuzumab deruxtecan (T-DXd) works for HER2-low advanced breast cancer.
- It's a non-interventional study, meaning no new drugs are given; it observes current treatments.
- Data will also be collected on other standard chemotherapy treatments.
- Participation involves sharing information from your existing medical care, not extra tests.
- You must have HER2-low advanced breast cancer and have had previous chemotherapy.
- This study aims to improve understanding for future patients with similar conditions.
Who may be eligible?
To be able to take part in this study, you need to be an adult (18 years or older) and have breast cancer that has been confirmed by a doctor. Your breast cancer must either be unable to be removed by surgery or have spread to other parts of your body. Also, your cancer cells need to show what is called “HER2-low status,” which a doctor will have checked.
You would have also had chemotherapy before for your advanced cancer, or your cancer must have come back within six months of finishing earlier chemotherapy treatment. The decision to start treatment with T-DXd or another standard chemotherapy would have been made by your doctor. Finally, you would need to read and sign a consent form to show you agree to be part of the 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?
- Has your doctor diagnosed you with breast cancer that has spread or cannot be removed by surgery?
- Has your doctor confirmed your breast cancer is 'HER2-low'?
- Have you had chemotherapy before for your advanced breast cancer, or did your cancer return early after finishing chemotherapy?
- Has your doctor decided you should start treatment with Trastuzumab deruxtecan or another standard chemotherapy?
- Are you able to provide written consent to participate?
What does participation involve?
If you join this study, you won't be given any new or experimental medicines. You will continue to receive your usual treatment (either T-DXd or standard chemotherapy) as decided by your doctor, just as you would if you weren't in the study. The study team will simply collect information about your health, your treatment, and how you're feeling from your medical records and during your regular doctor's visits. There are no extra visits or tests specifically for the study, and no follow-up beyond your usual medical care. The length of time you participate will depend on how long your treatment continues and what information the study needs to collect.
Potential risks and benefits
Locations (211)
- Medizinische Universität GrazVerified postcodeGraz, Austria· Terminated
- Medizinische Universität GrazVerified postcodeGraz, Austria· Active not recruiting
- Medizinische Universität InnsbruckVerified postcodeInnsbruck, Austria· Active not recruiting
- Klinikum Klagenfurt am WörtherseeVerified postcodeKlagenfurt, Austria· Active not recruiting
- LKH Hochsteiermark-LeobenVerified postcodeLeoben, Austria· Withdrawn
- Ordensklinikum Linz GmbH Barmherzige SchwesternVerified postcodeLinz, Austria· Active not recruiting
- Interne II, LKH FeldkirchVerified postcodeRankweil, Austria· Active not recruiting
- KH der Barmherzigen Brüder SalzburgVerified postcodeSalzburg, Austria· Active not recruiting
- Uniklinikum SalzburgVerified postcodeSalzburg, Austria· Active not recruiting
- Medical University of ViennaVerified postcodeVienna, Austria· Active not recruiting
- Medizinische Universität WienVerified postcodeVienna, Austria· Terminated
- Krankenhaus HietzingVerified postcodeVienna, Austria· Active not recruiting
Common questions
What is HER2-low breast cancer?
HER2-low breast cancer means your cancer cells have a small amount of a protein called HER2, but not enough to be called HER2-positive. This is important because it guides which treatments might work best.
Is this study giving me new medicine?
No, this study is not giving you any new or experimental medicine. It's observing how doctors already use approved treatments like Trastuzumab deruxtecan or other standard chemotherapies.
What does 'unresectable or metastatic' mean?
Unresectable means the cancer cannot be completely removed by surgery. Metastatic means the cancer has spread from where it started to other parts of the body.
Will I have extra doctor appointments if I join?
No, this study doesn't require any extra doctor appointments or special tests beyond your normal care. Information is collected during your regular visits.
Can I stop participating in the study at any time?
Yes, you can decide to stop being part of the study at any point, and this will not affect the medical care you receive from your doctor.
How to find out more
Contact for Clinical Trial Information
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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