A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)
This clinical trial, called TROPION-Breast03, is investigating new treatment options for a type of breast cancer called triple-negative breast cancer (TNBC) that is in stages I to III. Specifically, it's for people whose cancer still shows signs of disease after their first round of treatment (like chemotherapy) and surgery. The study is comparing two new drug combinations: Dato-DXd on its own, and Dato-DXd plus another drug called Durvalumab. These are being compared against standard treatments like Capecitabine and Pembrolizumab, which doctors might normally choose. The main goal is to see if the new combinations are better at preventing the cancer from coming back, and to check if they are safe to use. This is a Phase 3 study, meaning it's a large trial to confirm the benefits and safety of these new treatments.
At a glance
What is this study about?
This study, known as TROPION-Breast03, is focused on a specific type of breast cancer called triple-negative breast cancer (TNBC). This kind of cancer can sometimes be more challenging to treat. The trial is designed for people who have stage I to III TNBC and have already had initial treatments, including chemotherapy before surgery (called neoadjuvant therapy), but still have some cancer cells left in the breast or nearby lymph nodes after their surgery.
The researchers want to compare newer drug combinations with treatments that doctors might typically choose. The new drugs being tested are Dato-DXd, either by itself or combined with another drug called Durvalumab. These are being compared to standard treatments that your doctor might consider, such as Capecitabine and/or Pembrolizumab. The main aim is to find out if these new drugs can be more effective at stopping the cancer from returning, and to understand any side effects they might have.
This is a 'Phase 3' study, which is an important stage in drug development. It means a larger number of patients are involved, and the goal is to confirm whether the new treatments are better and safer than existing options. Finding more effective treatments is crucial for people with triple-negative breast cancer.
Key takeaways
- This study is for stage I-III triple-negative breast cancer.
- It's for people who still have cancer cells after initial treatment and surgery.
- It compares new drug combinations against standard treatments.
- The goal is to find more effective ways to prevent cancer recurrence.
- You will be closely monitored for safety and effectiveness.
Who may be eligible?
To join this study, you must be at least 18 years old. You need to have been diagnosed with triple-negative breast cancer that was stages I, II, or III. A key requirement is that after your initial chemotherapy and surgery, there were still some cancer cells found in your breast or nearby lymph nodes.
You should have completed at least six cycles of certain chemotherapy types before your surgery, and not have received any other cancer medication after your surgery but before joining the study. Your heart function should be good, and you should be generally well enough to participate, as assessed by your doctor. Importantly, you shouldn't have cancer spread to other parts of your body (stage IV).
There are also some medical conditions or previous treatments that would prevent you from taking part, such as a history of other invasive breast cancer, or severe medical issues that could make participating unsafe.
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 or older?
- Do you have stage I-III triple-negative breast cancer?
- Did you have chemotherapy before surgery?
- Were cancer cells still found after your surgery?
- Is your breast cancer not at stage IV (spread to other distant parts of the body)?
- Are you generally well and able to perform daily activities without major difficulty?
What does participation involve?
If you join this study, you will be assigned to one of three treatment groups. You will receive either Dato-DXd on its own, Dato-DXd with Durvalumab, or one of the standard treatments chosen by your doctor (Capecitabine or Pembrolizumab). The treatments are given through infusions (drips) or as pills, and you will have regular clinic visits, blood tests, and scans to monitor your health and the effects of the treatment.
This is an 'open-label' study, which means both you and your doctor will know which treatment you are receiving. The study involves ongoing treatment and visits, followed by regular check-ups to see how you are doing in the long term. The total duration of your active treatment will depend on the specific drugs you receive and how your body responds, but you will be followed for a significant period to track your health.
Potential risks and benefits
Locations (276)
- Research SiteVerified postcodeGilbert, United States
- Research SiteVerified postcodeTucson, United States
- Research SiteVerified postcodeTucson, United States
- Research SiteVerified postcodeHot Springs, United States
- Research SiteVerified postcodeLittle Rock, United States
- Research SiteVerified postcodeSpringdale, United States
- Research SiteVerified postcodeBeverly Hills, United States
- Research SiteVerified postcodeCosta Mesa, United States
- Research SiteVerified postcodeDuarte, United States
- Research SiteVerified postcodeFountain Valley, United States
- Research SiteVerified postcodeIrvine, United States
- Research SiteVerified postcodeLa Jolla, United States
Common questions
What is 'triple-negative breast cancer'?
Triple-negative breast cancer is a type of breast cancer that doesn't have the three most common 'receptors' (ER, PR, and HER2) that are often targeted by specific therapies. This means different treatment approaches are needed.
What does 'neoadjuvant therapy' mean?
Neoadjuvant therapy is treatment given before surgery. For breast cancer, this usually involves chemotherapy and is used to shrink the tumour before an operation.
What is a 'residual invasive disease'?
This means that after initial treatment and surgery, some cancer cells were still found in the breast or the nearby lymph nodes. The study aims to treat this remaining cancer.
Are the study drugs new?
Dato-DXd and Durvalumab are investigational drugs, meaning they are being tested to see how effective and safe they are compared to existing treatments.
Will I know which treatment I am getting?
Yes, this is an 'open-label' study, so both you and your doctor will know which specific treatment you are receiving.
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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