A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)
This important study, named TROPION-Breast02, is researching a new medicine called Dato-DXd for women and men with advanced triple-negative breast cancer. This is a type of breast cancer that has come back locally or spread to other parts of the body and can't be removed with surgery. The new medicine will be compared to standard chemotherapy choices given by doctors. This study is specifically for patients who are not suitable for a particular type of immunotherapy called PD-1/PD-L1 inhibitors. Researchers want to find out if Dato-DXd is more effective than current treatments at slowing down cancer growth and helping people live longer, while also checking for side effects. It's hoped that this new treatment could offer a better option for these patients.
At a glance
What is this study about?
This study, called TROPION-Breast02, is for people who have advanced triple-negative breast cancer. This means the cancer has either returned locally and can't be removed by surgery, or it has spread to other parts of the body (metastatic). 'Triple-negative' refers to the specific features of the cancer cells, which means certain common breast cancer treatments, like hormone therapy or HER2-targeted drugs, won't work.
The main goal of this research is to test a new medicine called Dato-DXd. This new drug will be compared to standard chemotherapy treatments that doctors would usually suggest. The doctors will choose the chemotherapy based on what they think is best for each patient from a list of options. The study is particularly interested in patients who are not able to receive a specific type of modern cancer treatment called PD-1/PD-L1 inhibitors, which are a kind of immunotherapy.
By comparing Dato-DXd with standard chemotherapy, researchers want to see two main things: firstly, if Dato-DXd is better at stopping the cancer from growing or spreading for a longer time (this is called 'progression-free survival'). Secondly, they want to see if people who take Dato-DXd live longer overall ('overall survival'). They will also keep a close eye on any side effects and how well patients tolerate the new medicine. It's hoped that Dato-DXd could become a new, effective treatment option for people with this type of breast cancer.
Key takeaways
- This study is testing a new medicine called Dato-DXd for advanced triple-negative breast cancer.
- It compares Dato-DXd to standard chemotherapy treatments.
- It's for people who cannot receive specific immunotherapy drugs.
- The aim is to find out if Dato-DXd is better at controlling cancer and helping people live longer.
- Participation involves regular hospital visits for treatment and monitoring.
- You will be randomly assigned to either Dato-DXd or standard chemotherapy.
Who may be eligible?
To be part of this study, you need to be at least 18 years old. You must have advanced triple-negative breast cancer that has returned locally and can't be operated on, or has spread to other parts of your body. Doctors will confirm that your cancer is indeed 'triple-negative' through special tests. Importantly, you should not have had any chemotherapy or other cancer treatments for this advanced breast cancer before joining the study.
Another key point is that you should not be suitable for PD-1/PD-L1 inhibitor immunotherapy. This could be because your cancer cells don't show specific markers (PD-L1 negative), or because you've had immunotherapy for early-stage breast cancer and it didn't work for long, or if you have other health conditions that make immunotherapy unsafe, or if this treatment isn't available where you live.
For the study, doctors will need to be able to measure your cancer using scans like CT or MRI. You'll also need to be generally well enough to take part, as assessed by your doctor, and able to consider one of the standard chemotherapy options the study is using. If you've had major surgery recently, you'll need to have recovered for at least 3 weeks before starting 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?
- Do you have advanced triple-negative breast cancer that has come back or spread?
- Have you not had chemotherapy for your advanced breast cancer before?
- Are you not suitable for PD-1/PD-L1 inhibitor immunotherapy (for reasons like your PD-L1 status, prior treatment, or other health issues)?
- Are you generally well enough for treatment, as assessed by your doctor?
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to one of two groups. One group will receive the new medicine, Dato-DXd, and the other group will receive a standard chemotherapy treatment chosen by your doctor. Neither you nor your doctor will know which treatment you are getting until you start.
You'll have regular hospital visits for treatments, check-ups, and tests like blood tests and scans (CT or MRI) to see how your cancer is responding. These visits will help the doctors monitor your health and the effects of the treatment. The total duration of your participation could vary, as you will continue treatment for as long as it is working for you and you are tolerating it well. After you stop treatment, there will still be follow-up calls or visits to see how you are doing.
Potential risks and benefits
Locations (228)
- Research SiteVerified postcodeDuarte, United States
- Research SiteVerified postcodeLos Angeles, United States
- Research SiteVerified postcodeSan Francisco, United States
- Research SiteVerified postcodeGrand Junction, United States
- Research SiteVerified postcodeLongmont, United States
- Research SiteVerified postcodeNew Haven, United States
- Research SiteVerified postcodeWashington D.C., United States
- Research SiteVerified postcodeMiami, United States
- Research SiteVerified postcodeMiami, United States
- Research SiteVerified postcodeAtlanta, United States
- Research SiteVerified postcodeLouisville, United States
- Research SiteVerified postcodeDetroit, United States
Common questions
What is 'triple-negative breast cancer'?
Triple-negative breast cancer is a type of breast cancer where the cancer cells don't have three specific features (receptors) that are often targeted by other breast cancer treatments. This means it needs different treatment approaches.
What is Dato-DXd?
Dato-DXd is a new medicine being tested in this study. It's designed to deliver a powerful medicine directly to cancer cells, aiming to be more effective and have fewer side effects on healthy cells.
Why can't I have PD-1/PD-L1 immunotherapy if I join this study?
This study is specifically looking at Dato-DXd for patients who are not suitable for or haven't responded well to a type of immunotherapy called PD-1/PD-L1 inhibitors. This helps researchers understand where Dato-DXd might fit in for patient care.
Will I definitely get the new medicine?
No, you will be randomly assigned to one of two groups. One group gets Dato-DXd, and the other gets a standard chemotherapy treatment chosen by your doctor. It's like flipping a coin for which treatment you receive.
What if the treatment isn't working for me?
Your doctors will regularly monitor your health and how your cancer is responding. If the treatment isn't working or if you experience severe side effects, your medical team will discuss stopping the study treatment and exploring other options with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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