A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)
This study, called DESTINY-Breast05, is for adults with a type of breast cancer called HER2-positive. If you've had initial treatments (like chemotherapy and other targeted drugs) but still have some cancer left, this study might be for you. We're directly comparing two medicines, trastuzumab deruxtecan (T-DXd) and trastuzumab emtansine (T-DM1), to see which one is more effective at preventing the cancer from returning. These medicines are given after surgery to help reduce the risk of the cancer spreading or coming back. The main goal is to find out if T-DXd can keep the cancer away for longer compared to T-DM1.
At a glance
What is this study about?
When someone has HER2-positive breast cancer, it means the cancer cells have too much of a protein called HER2, which helps them grow. Patients usually have treatments like chemotherapy and HER2-targeted drugs before surgery. For some people, even after these initial treatments, a small amount of cancer might still be present. This is called 'residual invasive breast cancer,' and it means there's a higher chance the cancer could come back in the future. Because of this, doctors are always looking for better ways to keep the cancer from returning.
This study aims to find a more effective treatment for these patients. We're comparing two existing medicines: trastuzumab deruxtecan (T-DXd) and trastuzumab emtansine (T-DM1). Both are targeted therapies specifically designed to attack HER2-positive cancer cells. By comparing them directly, researchers hope to discover if one is significantly better at stopping the cancer from recurring. This could lead to improved care for people facing this particular challenge with breast cancer.
The main thing we're looking at is called 'invasive disease-free survival.' This means we want to see how long people stay free from the cancer coming back or spreading to other parts of their body. We'll also look at other important things like overall survival and how the treatments affect people's quality of life. The study will help doctors make better choices about what treatment to offer patients who have this higher risk of their cancer returning.
Key takeaways
- Tests two existing HER2-targeted drugs, T-DXd and T-DM1.
- For HER2-positive breast cancer patients who still have some cancer after initial treatment.
- Aims to find out which drug is better at stopping cancer from returning.
- Participation involves regular treatments, clinic visits, and long-term follow-up.
- Could offer a new or more effective treatment option.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old. You must have been diagnosed with HER2-positive breast cancer, which has been confirmed by tests. This cancer must have been present in a way that, at the start, was not a very small T1N0 tumour. Also, after your first set of treatments (like chemotherapy and other HER2 medicines before surgery), tests must show that some breast cancer cells were still present in your breast or the lymph nodes in your armpit.
Your breast cancer also needs to be considered 'high-risk' for returning. This means either your cancer was quite advanced and couldn't be easily operated on when it was first found, or if it was operable, the lymph nodes in your armpit still showed signs of cancer after your initial treatments. You must have completed your original treatments, including surgery to remove the cancer, within 12 weeks before you would start the study treatment.
All your previous treatments, like chemotherapy and HER2-targeted therapy, must have been given for a certain amount of time. You also need to have generally good health and your body systems, like your blood and liver, must be working well as shown by medical tests. This helps make sure you are well enough to take part in the study and potentially handle the new treatments.
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 been confirmed by a doctor?
- Did you have some cancer remaining after your initial treatments and surgery?
- Was your cancer considered 'high-risk' for returning at the time of diagnosis or after initial treatment?
- Have you completed all your previous initial treatments for breast cancer?
- Was your surgery completed within the last 12 weeks?
What does participation involve?
If you join this study, you will receive one of the two study medicines, either T-DXd or T-DM1. These drugs are usually given through a drip into your vein. You will have regular hospital visits for these treatments and to monitor your health and how you're responding. This will include blood tests, physical examinations, and scans (like CT or MRI scans) to check the cancer.
The treatment part of the study could last for about a year. During that time, you'll continue to receive your assigned medication on a regular schedule. After the treatment phase, there will be a follow-up period where doctors will keep track of your health, even if you're no longer receiving the study drug. This follow-up will continue for several years to see how you're doing long-term. The total duration of your participation, including treatment and follow-up, could be several years.
Potential risks and benefits
Locations (482)
- The Oncology Institute of Hope & InnovationVerified postcodeAnaheim, United States
- Kaiser PermanenteVerified postcodeAnaheim, United States
- Kaiser PermanenteVerified postcodeBaldwin Park, United States
- Kaiser PermanenteVerified postcodeBellflower, United States
- Kaiser PermanenteVerified postcodeFontana, United States
- Orange Coast Blood and Cancer CareVerified postcodeFountain Valley, United States
- Kaiser PermanenteVerified postcodeHarbor City, United States
- Kaiser PermanenteVerified postcodeIrvine, United States
- Long Beach Memorial TCIVerified postcodeLong Beach, United States
- Kaiser PermanenteVerified postcodeLos Angeles, United States
- Kaiser PermanenteVerified postcodeOntario, United States
- Kaiser PermanenteVerified postcodePanorama City, United States
Common questions
What does 'HER2-positive' mean?
HER2-positive means your cancer cells have a particular protein called HER2 on their surface, which helps them grow. Treatments that target this protein can be very effective.
What is 'residual invasive breast cancer'?
This means that after your initial treatments (like chemotherapy and targeted drugs) and surgery, a small amount of cancer cells were still found. This suggests a higher chance of the cancer returning.
Are these new medicines?
Both T-DXd and T-DM1 are targeted therapies for HER2-positive breast cancer. T-DM1 is already an established treatment, and T-DXd is also an approved medication, though its use in this specific situation is what's being studied here.
Will I know which drug I'm getting?
Because this is a comparison study, participants are usually put into groups by chance (like flipping a coin) to receive one treatment or the other. Often, neither you nor your doctor will know which drug you are receiving until the study is over, so the results are fair.
What happens if the cancer comes back during the study?
Your health will be closely monitored. If the cancer does return, your study doctor will discuss your options for further treatment with you, which may include leaving the study and starting a different treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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