A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
This study investigates new treatment options for a specific type of breast cancer known as triple-negative breast cancer (TNBC) that has either returned locally and can't be operated on, or has spread to other parts of the body. It's a Phase 3 study, meaning it's comparing new treatments to existing ones to see which is more effective and safer. Patients will be randomly assigned to receive either the new drug Dato-DXd (sometimes combined with Durvalumab) or standard chemotherapy (such as Paclitaxel, Nab-paclitaxel, Gemcitabine, or Carboplatin) along with Pembrolizumab. The main goal is to see if the new treatments can help patients live longer without their cancer worsening and to improve their overall quality of life.
At a glance
What is this study about?
This study is a research project focusing on a type of breast cancer called triple-negative breast cancer (TNBC). This kind of cancer can sometimes be challenging to treat, especially if it returns to the area it started in and can't be removed with surgery, or if it has spread to other parts of the body (this is called metastatic cancer).
The study aims to find better ways to treat TNBC. Researchers are comparing a new drug called Dato-DXd (sometimes given with another drug called Durvalumab) against treatments that are currently considered standard care. The standard care in this study involves a specific chemotherapy drug (like Paclitaxel, Nab-paclitaxel, Gemcitabine, or Carboplatin) combined with Pembrolizumab, which is a type of immunotherapy. The main hope is that the new treatments will help patients live longer without their cancer getting worse, and potentially improve their quality of life.
This is a Phase 3 study, which means it's one of the final stages of testing new treatments before they might be made available more widely. Patients taking part will be randomly assigned to one of the treatment groups, and doctors will carefully monitor how effective and safe each treatment is. They'll also look at how the treatments affect patients' day-to-day lives.
Key takeaways
- Investigates new treatments for triple-negative breast cancer that has returned or spread.
- Compares experimental drugs (Dato-DXd, Durvalumab) with standard chemotherapy plus Pembrolizumab.
- Aims to see if new treatments can help patients live longer without cancer worsening.
- Includes assessments of quality of life.
- Participants are randomly assigned to a treatment group.
- Open-label study, meaning you will know which treatment you are receiving.
Who may be eligible?
To join this study, you would need to have triple-negative breast cancer that has either come back locally and can't be removed by surgery, or has spread to other parts of your body. Your cancer would also need to show a particular marker called PD-L1 which helps identify if certain treatments might work.
You cannot have had chemotherapy or other anti-cancer treatments for your widespread breast cancer yet. If you previously had treatment for earlier-stage breast cancer, at least six months must have passed since you finished that treatment. You also need to be generally well, able to carry out your daily activities, and meet certain health criteria regarding your blood and organ function.
There are also some reasons why you might not be able to join, such as having certain other serious medical conditions (like uncontrolled high blood pressure or heart problems), ongoing infections, or a history of significant gastrointestinal issues. Your doctor will carefully review your medical history to make sure the study is a safe and appropriate option for you.
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.
- Do I have triple-negative breast cancer that has come back locally and can't be removed, or has spread?
- Has my doctor confirmed my cancer shows the PD-L1 marker?
- Have I not yet received chemotherapy or other anti-cancer treatment for my widespread breast cancer?
- If I had previous breast cancer treatment, did I finish it at least 6 months ago?
- Am I generally well and able to carry out most daily activities?
- Am I willing to use specific birth control methods if needed?
What does participation involve?
If you join this study, you will be randomly assigned to one of the treatment groups. You will receive either the new drug Dato-DXd (possibly with Durvalumab) or standard chemotherapy combined with Pembrolizumab. You will have regular hospital visits for treatments, blood tests, scans (like CT or MRI scans) to check on your cancer, and discussions with the study doctor and nurses about how you are feeling. The frequency of these visits and tests will vary over the course of the study. You will also be asked to complete questionnaires to assess your quality of life. The total duration of your participation in the study will depend on how your cancer responds to treatment, and you'll continue to be monitored for a period after treatment finishes.
Potential risks and benefits
Locations (316)
- Research SiteVerified postcodeDaphne, United States· Recruiting
- Research SiteVerified postcodeSpringdale, United States· Recruiting
- Research SiteVerified postcodeDuarte, United States· Withdrawn
- Research SiteVerified postcodeGlendale, United States· Recruiting
- Research SiteVerified postcodeSacramento, United States· Recruiting
- Research SiteVerified postcodeSanta Rosa, United States· Withdrawn
- Research SiteVerified postcodeAurora, United States· Recruiting
- Research SiteVerified postcodeNew Haven, United States· Recruiting
- Research SiteVerified postcodeJacksonville, United States· Withdrawn
- Research SiteVerified postcodeMiami, United States· Recruiting
- Research SiteVerified postcodePalm Bay, United States· Withdrawn
- Research SiteVerified postcodePlantation, United States· Recruiting
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' that other breast cancers might have. This means it doesn't respond to treatments that target those receptors, requiring different approaches.
What does 'Phase 3' mean for a clinical trial?
Phase 3 is a late stage of clinical trial. It means a new treatment is being compared to existing standard treatments in a larger group of people to confirm its effectiveness, monitor side effects, and compare it to commonly used options.
What are Dato-DXd, Durvalumab, and Pembrolizumab?
These are different types of medicines. Dato-DXd is an experimental drug, while Durvalumab and Pembrolizumab are immunotherapies, which work by helping your body's own immune system fight cancer cells. The chemotherapy drugs are common cancer treatments that kill fast-growing cells.
Will I know which treatment I am receiving?
Yes, this is an 'open-label' study, which means both you and your study doctor will know which specific treatment you are receiving.
What happens after the study treatment finishes?
After your treatment phase, you will continue to have follow-up visits and assessments for a period of time to monitor your health and how your cancer is doing.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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