Active not recruitingPHASE3INTERVENTIONAL

A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer

This international study is testing a new treatment called Trastuzumab Deruxtecan (T-DXd) for people with advanced or metastatic HER2-positive breast cancer. This is for patients whose cancer has grown even after previous HER2-targeted treatments, and who have received no more than two other treatments for their metastatic cancer. The study aims to understand how well T-DXd works and if it's safe. It's unique because it includes patients both with and without cancer that has spread to the brain (brain metastases). Patients will be followed up after treatment to monitor their health and the effects of the treatment, including how long they live and what other treatments they might receive.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

506

Start

22 Jun 2021

Estimated completion

26 May 2027

Breast Cancer

Results

Results from this study

Posted May 2025

Results have been published for this study.

Primary outcome

Objective Response Rate (ORR) in Cohort 1 (Participants Without Brain Metastasis at Baseline)

The ORR is defined as the percentage (%) of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by independent central review (ICR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Full results on the registry

What is this study about?

This study is focusing on a type of breast cancer called HER2-positive. This means the cancer cells have a lot of a protein called HER2, which can make them grow and spread. The study is for people whose HER2-positive breast cancer is considered advanced or metastatic, meaning it has spread to other parts of the body, and has already been treated with other medicines.

The main aim is to see how effective and safe a new medicine, Trastuzumab Deruxtecan (T-DXd), is for these patients. T-DXd is a treatment that targets HER2-positive cancer cells. Researchers want to understand if it can help stop the cancer from growing or even shrink it, and what side effects it might have. This is an 'open-label' study, which means both the patients and their doctors will know they are receiving T-DXd.

An important aspect of this study is that it includes patients both with and without cancer that has spread to the brain (known as brain metastases). This helps researchers understand how T-DXd might work for a wider range of patients with advanced HER2-positive breast cancer. By gathering this information, doctors can learn more about the best ways to treat this condition in the future.

Key takeaways

Tests a new treatment (T-DXd) for advanced HER2-positive breast cancer.
For patients whose cancer has progressed after previous treatments.
Includes patients with or without cancer spread to the brain.
Aims to assess both effectiveness and safety of the new treatment.
Involves regular check-ups and long-term follow-up after treatment.

Who may be eligible?

This study is looking for around 500 people with advanced or metastatic HER2-positive breast cancer who have already had treatment for it. Your cancer must have been confirmed as HER2-positive by a specialist test, and it should have grown or progressed after your previous HER2-targeted treatments. You should not have had more than two lines of treatment for your advanced or metastatic cancer.

An important part of this study is that it includes people with or without cancer that has spread to the brain (brain metastases). If you have brain metastases, they must not need urgent treatment, or they must be stable or have already been treated. You'll need to be feeling well enough to take part, as measured by a standard health score called ECOG Performance Status, which should be 0 or 1.

To be considered, your heart and other organs, including your bone marrow, need to be working well. If you are a woman who could become pregnant, you would need to have a negative pregnancy test. The study is for adults aged 18 and over.

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 you have advanced or metastatic HER2-positive breast cancer?
Has your cancer progressed after previous HER2-targeted treatments?
Have you had no more than two other treatments for your metastatic cancer?
Are you generally feeling well and able to carry out daily activities?
If you have cancer spread to the brain, is it stable or not needing urgent treatment?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be one of approximately 500 participants and will be placed into one of two groups: either with or without brain metastases. You'll receive the study treatment, Trastuzumab Deruxtecan. Throughout the study, you'll have regular hospital visits for check-ups, assessments, and to monitor your health and how the treatment is affecting you. These visits will involve various tests, scans, and physical examinations.

After you stop receiving the study treatment, you'll have a final check-up visit within 7 days. Your safety will continue to be monitored for about 40 to 47 days after your last dose. Following this, you'll be contacted every three months for follow-up to check on your health, survival status, and any other treatments you might start. This follow-up will continue until the study ends or if you decide to stop participating.

Potential risks and benefits

Taking part in a clinical study means you could potentially benefit from a new treatment that isn't yet widely available, and you'll receive close medical attention. However, there are potential risks, as any medication can have side effects. These will be explained to you in detail by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (81)

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

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Boston, United States
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Durham, United States
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Adelaide, Australia
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Auchenflower, Australia
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Clayton, Australia
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Heidelberg, Australia
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St Leonards, Australia
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Subiaco, Australia
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Anderlecht, Belgium
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Bruges, Belgium
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Leuven, Belgium
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Liège, Belgium

Common questions

What is HER2-positive breast cancer?

This is a type of breast cancer where the cancer cells have a lot of a protein called HER2, which helps them grow and spread.

What does 'metastatic' mean?

Metastatic means the cancer has spread from where it started to other parts of the body.

What are brain metastases?

Brain metastases are when cancer from another part of the body, like the breast, spreads to the brain.

Will I know if I'm getting the study drug?

Yes, this is an 'open-label' study, meaning everyone, including you and your doctor, will know you are receiving Trastuzumab Deruxtecan.

How long will I be involved in the study?

You'll receive treatment for a period, followed by regular safety checks for a few weeks, and then long-term follow-up every three months until the study ends.