Active not recruitingPHASE3INTERVENTIONAL

Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)

This research study is about finding better ways to treat HER2-positive breast cancer that has spread to other parts of the body (called metastatic). We are looking at a new treatment called trastuzumab deruxtecan (T-DXd), sometimes with another drug called pertuzumab. We want to see if these new treatments are more effective and safer than the usual treatment. This is the first treatment patients will receive for their metastatic breast cancer. The study will check if these new approaches can help patients live longer without their cancer getting worse, or simply live longer overall. We'll also be looking at how these treatments affect patients' day-to-day lives and overall well-being.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,157

Start

26 Apr 2021

Estimated completion

30 Dec 2029

Breast Cancer; HER2-positive; Metastatic

What is this study about?

This study is for people with a type of breast cancer called HER2-positive. 'HER2-positive' means that the cancer cells have a lot of a protein called HER2 on their surface, which can make the cancer grow faster. When breast cancer has spread to other parts of the body, it's called metastatic breast cancer, and treatments aim to control the cancer and improve quality of life.

The main goal of this study is to test a new treatment called trastuzumab deruxtecan (T-DXd). This drug is designed to attack HER2-positive cancer cells more directly. We're also looking at whether adding another drug, pertuzumab, to T-DXd makes it even more effective. These new treatments are being compared to the standard treatment currently used for this type of breast cancer, which usually involves a chemotherapy drug (like taxane), trastuzumab, and pertuzumab.

Researchers want to find out if T-DXd, either on its own or with pertuzumab, can help patients live longer without their cancer growing or spreading further, or if it can help them live longer overall. They will also be carefully monitoring for any side effects and how these treatments affect a person's general well-being and daily activities. This is important research because it could lead to new and better treatment options for people with HER2-positive metastatic breast cancer.

Key takeaways

This study is testing new treatments for HER2-positive breast cancer that has spread.
It compares an experimental drug, T-DXd, to the current standard treatment.
The aim is to see if the new treatments are more effective and safe.
You will be randomly assigned to receive one of the study treatments.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

To join this study, you must be 18 years or older and have breast cancer that has spread (metastatic breast cancer). Your cancer needs to be confirmed as HER2-positive. This study is for people who have not yet had any chemotherapy or specific HER2-targeted treatments for their widespread breast cancer. If you had these treatments when your cancer was in an earlier stage, you might still be able to join if it’s been more than six months since those treatments ended.

You'll also need to be fit enough to take part, meaning certain organs (like your liver and kidneys) and your blood count should be working well. Your general health and ability to do daily activities should also be good, which is often described by a score from 0 (fully active) to 1 (restricted in strenuous activity).

There are some reasons you might not be able to join. For example, if you have certain existing lung problems, uncontrolled cancer in your brain or spinal cord, or other serious medical conditions that might interfere with the study. You also can't participate if you've already been in a study testing trastuzumab deruxtecan before.

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 breast cancer that has spread (metastatic)?
Has your cancer been confirmed as HER2-positive?
Have you NOT received chemotherapy or HER2-targeted treatment for your current widespread cancer?
Are you generally well and able to manage daily activities (ECOG 0 or 1)?
Are you free from certain lung conditions or uncontrolled cancer in the brain/spine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive one of the study treatments, either the new drug combination or the standard treatment, given through an injection or infusion. The treatments will continue for as long as your cancer is responding well, or until side effects become too difficult to manage. You will need to come to the hospital or clinic regularly for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. You will also be asked about your quality of life. The doctors and nurses will explain the exact schedule of visits and tests, which will depend on which treatment group you are in. Throughout the study, your health will be closely monitored by the study team.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as receiving close medical attention and access to new treatments before they are widely available, which may be more effective than current standard care. However, there are also potential risks, including side effects from the study medications, which could be unpleasant or serious, and the possibility that the new treatment may not work for you. The exact risks and benefits of each treatment option will be fully explained by the study team. 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 future 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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Tucson, United States
Research Site
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Springdale, United States
Research Site
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Glendale, United States
Research Site
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Glendale, United States
Research Site
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Longmont, United States
Research Site
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Miami, United States
Research Site
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Palm Bay, United States
Research Site
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Plantation, United States
Research Site
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Atlanta, United States
Research Site
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Louisville, United States
Research Site
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Silver Spring, United States
Research Site
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Boston, United States

Common questions

What does 'HER2-positive' mean?

HER2-positive means that your breast cancer cells have too much of a specific protein called HER2, which helps the cancer grow. Treatments targeting HER2 can be very effective.

What is 'metastatic breast cancer'?

Metastatic breast cancer means the cancer has spread from the breast to other parts of your body. The goal of treatment is usually to control the cancer and improve your quality of life.

What is trastuzumab deruxtecan (T-DXd)?

Trastuzumab deruxtecan is a newer type of drug designed to deliver powerful chemotherapy directly to HER2-positive cancer cells while trying to limit the impact on healthy cells.

Will I definitely get the new drug if I join?

No, this is a 'randomised' study. This means you will be randomly assigned to receive either the new drug (with or without pertuzumab) or the current standard treatment. You won't be able to choose.

How long will I be on the study treatment?

You will receive the study treatment for as long as it is working well for you and you are not experiencing severe side effects. Your doctor will monitor this closely.