Active not recruitingPHASE3INTERVENTIONAL

A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

This research study is comparing two different treatment approaches for a specific type of breast cancer. This type is called triple-negative or hormone receptor-low/HER2-negative breast cancer, meaning it lacks certain hormone receptors and the HER2 protein. The study involves giving treatments both before and after surgery. One treatment plan uses Dato-DXd and durvalumab, and the other uses pembrolizumab along with standard chemotherapy. Researchers want to see if one approach is more effective and safer at preventing the cancer from coming back, or if it helps people live longer without the cancer returning. This is a crucial step in finding better ways to help people with this challenging form of breast cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,902

Start

14 Nov 2023

Estimated completion

23 Sep 2032

Breast Cancer

What is this study about?

This research study is an important step in finding better treatments for a specific type of breast cancer. This cancer is known as triple-negative or hormone receptor-low/HER2-negative breast cancer. This simply means that the cancer cells don't have certain 'receptors' (like tiny antennae) found on other types of breast cancer, which can make it harder to treat with some targeted therapies. The study is comparing two different ways to treat this type of cancer.

Patients taking part will receive treatment both before surgery (called 'neoadjuvant' treatment) and after surgery (called 'adjuvant' treatment). One group will receive a combination of two new medicines, Dato-DXd and durvalumab, before surgery, followed by more durvalumab with or without chemotherapy after surgery. The other group will receive pembrolizumab, another newer medicine, along with standard chemotherapy before surgery, followed by more pembrolizumab, with or without chemotherapy, after surgery.

The main goal is to find out if one of these treatment plans is better at stopping the cancer from coming back or spreading, and if it's safe for patients. By comparing these different approaches, doctors hope to learn more about which treatments work best for people with triple-negative or hormone receptor-low/HER2-negative breast cancer.

Key takeaways

This study is comparing two different treatment plans for a specific type of breast cancer.
It tests newer medicines alongside standard chemotherapy, both before and after surgery.
The main goal is to find more effective and safer ways to treat triple-negative or hormone receptor-low/HER2-negative breast cancer.
Participation involves regular hospital visits for treatments and check-ups over an extended period.
You have the right to withdraw from the study at any time.
All treatment decisions will be made with careful consideration of your individual health and circumstances.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with Stage II or III triple-negative or hormone receptor-low/HER2-negative breast cancer that hasn't been treated before. You'll also need to be generally fit and well enough for the treatments, as assessed by your doctor.

There are several reasons why you might not be able to join. For example, if you've already been treated for breast cancer, or if you've had certain other cancers recently. Also, if you have certain serious health conditions like uncontrolled heart problems, severe lung issues, or active autoimmune diseases, you wouldn't be able to participate. They also can't include pregnant or breastfeeding women.

Before you can take part, your medical team will carefully review your health and medical history to make sure the study is a safe and suitable 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.

Are you 18 years old or older?
Have you been diagnosed with Stage II or III triple-negative or hormone receptor-low/HER2-negative breast cancer?
Have you NOT received any prior treatment for this breast cancer?
Are you generally fit and well, able to perform daily activities without significant difficulty?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the hospital or clinic. You would receive a combination of different medicines over a period of time, both before and after surgery. This would involve regular appointments for treatments, check-ups, blood tests, and scans to monitor your health and how the treatment is working. You'll also need to provide a sample of your tumour tissue.

The total duration of your participation, including follow-up appointments, could extend for several years to track your progress and see the long-term effects of the treatments. Your study team will explain the full schedule of visits, tests, and medication details carefully before you make any decisions.

Potential risks and benefits

Participating in a clinical trial can offer potential benefits, such as access to new treatments that might be more effective than current standard options. However, there are also potential risks involved. The new medicines might have side effects that are not fully known yet, or they might not work as expected. Your doctors and the study team will monitor you very closely for any side effects and manage them as best they can. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (283)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Research Site
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Daphne, United States
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Prescott, United States
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Jonesboro, United States
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Rogers, United States
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Los Angeles, United States
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Santa Barbara, United States
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Santa Rosa, United States
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Torrance, United States
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Aurora, United States
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Longmont, United States
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Bridgeport, United States
Research Site
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New Haven, United States

Common questions

What is 'triple-negative' breast cancer?

It's a type of breast cancer where the cancer cells don’t have certain 'receptors' that other breast cancers might have, making it harder to treat with some specific therapies.

What does 'neoadjuvant' and 'adjuvant' treatment mean?

'Neoadjuvant' means treatment given before surgery to shrink the cancer, and 'adjuvant' means treatment given after surgery to help stop it from coming back.

Are the medicines in this study new?

Some of the medicines are newer, and some are standard chemotherapy drugs, all being tested in specific combinations to see if they improve outcomes for this type of breast cancer.

How long would I be in the study?

Participation involves treatment periods before and after surgery, combined with regular follow-up appointments, which could last for several years to monitor your health long-term.

Can I leave the study if I change my mind?

Yes, you have the right to leave the study at any time, for any reason, without it affecting your standard medical care.