DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]
This important study, called DESTINY-Breast03, is looking into two different medicines for a type of breast cancer called HER2-positive breast cancer. This is for cancer that has spread or cannot be removed by surgery, and where patients have already received treatments like trastuzumab and a taxane. The main goal is to see if one medicine, trastuzumab deruxtecan, is better than another, trastuzumab emtansine (T-DM1), at fighting the cancer. The researchers will also carefully check if the medicines are safe and how well patients respond. This could help doctors decide the best way to treat this type of breast cancer in the future.
At a glance
Results
Results from this study
Posted April 2022Results have been published for this study.
What is this study about?
This study, known as DESTINY-Breast03, is focused on improving treatments for a specific type of breast cancer. Cancer cells sometimes have a protein called HER2 on their surface. If your cancer has a lot of this protein, it's called HER2-positive breast cancer. This study is for people whose HER2-positive breast cancer has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable).
If you're considering this study, it's because your cancer has already been treated with certain medicines in the past, specifically trastuzumab and a type of chemotherapy called a taxane. The study wants to compare two different medicines: trastuzumab deruxtecan and trastuzumab emtansine (T-DM1). Both are targeted treatments, meaning they are designed to specifically attack HER2-positive cancer cells.
By comparing these two treatments, the doctors hope to find out which one works better at shrinking or controlling the cancer and which one has a more manageable safety profile. This information is vital for helping future patients with HER2-positive breast cancer get the most effective treatment possible. Participating in a study like this helps advance medical knowledge and improve care for others.
Key takeaways
- This study is for advanced HER2-positive breast cancer.
- It compares two targeted treatments: trastuzumab deruxtecan and T-DM1.
- Participants must have already received trastuzumab and a taxane.
- The goal is to find out which treatment works best and is safest.
- You'll be closely monitored with regular visits and tests.
Who may be eligible?
To join this study, you need to be an adult aged 18 or over with breast cancer that has been identified as HER2-positive. Your cancer must have either spread to other parts of your body or be a type that doctors cannot remove with surgery. You would also need to have received previous treatments for your cancer, including trastuzumab and a type of chemotherapy called a taxane.
Doctors will also need to see that your cancer has shown signs of growing or spreading since your last treatment. They will examine your most recent tumour tissue to confirm it is HER2-positive, and if a sample isn't available, you might need a new tiny sample (biopsy) taken. You must also have at least one area of cancer that can be measured on scans.
There are some reasons why you might not be able to join. For example, if you've already had a specific anti-HER2 treatment called an ADC (like T-DM1) for your advanced cancer. Also, if you have certain heart conditions that are not well-controlled, such as a recent heart attack or certain types of heart failure, you might not be eligible.
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-positive breast cancer that has spread or can't be removed by surgery?
- Have you already been treated with trastuzumab and a taxane for your cancer?
- Has your cancer shown signs of growing or spreading since your last treatment?
- Do you have a heart condition that is well-controlled?
- Have you *not* had another ADC anti-HER2 treatment (like T-DM1) for your advanced cancer?
What does participation involve?
If you decide to take part in this study, you would receive one of the two study treatments. You'd have regular visits with the study team to monitor your health, check for any side effects, and see how the treatment is working. These visits would likely involve physical exams, blood tests, and scans (like X-rays or CT scans) to measure your cancer.
The treatment would be given on a regular schedule, and the study team would explain exactly how and when you'd receive it. You'd continue participating for as long as the treatment is helping you and you're not experiencing severe side effects. Following the active treatment period, there would be a follow-up phase where the study team would continue to check on your health over time, even after you stop receiving the study medication. The total duration of your participation would involve the treatment period and then a period of follow-up.
Potential risks and benefits
Locations (164)
- UCLA Hematology OncologyVerified postcodeLos Angeles, United States
- Sharp Memorial HospitalVerified postcodeSan Diego, United States
- University of California San FranciscoVerified postcodeSan Francisco, United States
- Innovative Clinical Research InstituteVerified postcodeWhittier, United States
- Washington Cancer InstituteVerified postcodeWashington D.C., United States
- Florida Cancer Specialists-BroadwayVerified postcodeFort Myers, United States
- Florida Cancer Specialists NORTHVerified postcodeSt. Petersburg, United States
- Piedmont Cancer Institute, PCVerified postcodeAtlanta, United States
- Loyola University Health SystemVerified postcodeMaywood, United States
- Norton Cancer InstituteVerified postcodeLouisville, United States
- Dana-Farber Cancer InstituteVerified postcodeBoston, United States
- University of Nebraska Medical CenterVerified postcodeOmaha, United States
Common questions
What is HER2-positive breast cancer?
HER2-positive breast cancer means the cancer cells have a lot of a protein called HER2 on their surface. This protein can help cancer cells grow, so treatments often target it.
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.
What are trastuzumab and a taxane?
These are common treatments for HER2-positive breast cancer. Trastuzumab is a targeted drug, and a taxane is a type of chemotherapy.
How long will the study last?
The study will involve a period of receiving treatment and then a follow-up period to monitor your health over time. Your study team can give you more specific details based on your situation.
Will I know which treatment I am getting?
In some studies, you might not know which treatment you are receiving (this is called 'blinding'). The study team will explain how this particular study is designed and what to expect.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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