RecruitingOBSERVATIONAL

PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan

This is a study for people in Germany with breast cancer that has spread or can't be removed by surgery and is HER2-positive, HER2-low, or HER2-ultralow. Researchers want to understand how a treatment called trastuzumab deruxtecan (T-DXd) works for these patients in their daily lives, as part of their routine care. It's not testing a new drug or treatment approach, but rather observing how the approved treatment is used and what its effects are. The study will collect information on how patients feel (patient-reported outcomes) as well as information about the treatment's effectiveness and any side effects. Participants will also learn about digital health tools. Around 800 patients will be included in total.

At a glance

Status

Recruiting

Sponsor

AstraZeneca

Enrolment target

800

Start

12 Sep 2023

Estimated completion

31 Dec 2031

Breast Neoplasms Breast Cancer Neoplasm Metastasis

What is this study about?

This study, called PROVIDENCE, is looking at how a specific treatment for advanced breast cancer, called trastuzumab deruxtecan (T-DXd), works for patients in their everyday lives. It's for people whose breast cancer has spread to other parts of the body (metastatic) or can't be surgically removed (unresectable), and is identified as HER2-positive, HER2-low, or HER2-ultralow. These terms refer to certain proteins found on cancer cells.

The main goal is to understand how well the treatment works in a real-world setting, meaning when it's given as part of standard care, not in a highly controlled research environment. The study will also collect information directly from patients about how they are feeling, their quality of life, and their experiences with the treatment. This helps doctors and researchers understand the full picture of living with advanced breast cancer and receiving T-DXd.

It's important to know that this is not a study where you'd be trying a new, experimental drug or getting a treatment that isn't already available. Instead, it's observing the effects of a treatment that doctors are already prescribing. The study aims to gather valuable information from about 800 patients to better understand how T-DXd performs outside of very strict clinical trial conditions.

Key takeaways

It's about an existing breast cancer treatment, not a new one.
The study watches how the treatment works in routine care.
It covers advanced breast cancer that is HER2-positive, HER2-low, or HER2-ultralow.
Patient experiences and feelings are an important part of the data being collected.
Your medical care and treatment decisions remain with your doctor.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) with breast cancer that has spread or cannot be removed by surgery. Your cancer must have been identified as HER2-positive, HER2-low, or HER2-ultralow by your doctors.

You would also need to have already received some previous treatments. For example, if your cancer is HER2-positive, you would have had treatment specifically for HER2. If your cancer is HER2-low or HER2-ultralow and sensitive to hormones, you would have already tried hormone therapy. If it's HER2-low, you might have had chemotherapy. Importantly, your doctors must also have determined that the treatment being studied, trastuzumab deruxtecan (T-DXd), is the right treatment for you according to current medical guidelines, and you should be about to start it.

You cannot join if you've already been receiving T-DXd for more than 30 days, are pregnant or breastfeeding, or are allergic to the medication. Also, if you're taking part in another clinical study that involves a treatment, or are planning to, you wouldn't be able to participate in this one.

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?
Do you have advanced breast cancer that has spread or can't be removed?
Has your cancer been identified as HER2-positive, HER2-low, or HER2-ultralow?
Are you about to start trastuzumab deruxtecan (T-DXd) treatment?
Have you *not* been receiving T-DXd for more than 30 days already?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the breast cancer treatment trastuzumab deruxtecan (T-DXd) as your doctor normally prescribes it. The study will not change your treatment plan, the tests you have, or how often you see your doctor. All these decisions will remain with your doctor, as part of your routine care.

The study involves doctors collecting information about your treatment, how well it's working, and any side effects you might experience. You will also be asked to share how you are feeling and your overall wellbeing, which is called 'patient-reported outcomes'. Additionally, you will be given information about digital healthcare applications that might help manage your health. The total duration of your participation will depend on how long your doctor determines you should receive the treatment.

Potential risks and benefits

The potential benefits of taking part include contributing to a better understanding of how trastuzumab deruxtecan (T-DXd) works in real-world settings, which can help other patients in the future. You will receive standard care for your condition, and your treatment will be overseen by your doctor as usual. Since you would be receiving this treatment anyway, the risks are generally the same as those associated with the T-DXd treatment itself, which your doctor will discuss with you. There are no additional experimental treatments involved. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (107)

Research Site
Verified postcode
Amberg, Germany· Withdrawn
Research Site
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Ansbach, Germany· Withdrawn
Research Site
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Apolda, Germany· Recruiting
Research Site
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Aschaffenburg, Germany· Recruiting
Research Site
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Augsburg, Germany· Recruiting
Research Site
Verified postcode
Augsburg, Germany· Recruiting
Research Site
Verified postcode
Bad Reichenhall, Germany· Recruiting
Research Site
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Baden-Baden, Germany· Recruiting
Research Site
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Balingen, Germany· Recruiting
Research Site
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Bamberg, Germany· Recruiting
Research Site
Verified postcode
Berlin, Germany· Recruiting
Research Site
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is the main goal of this study?

The study aims to understand how trastuzumab deruxtecan (T-DXd) works in daily medical practice for patients with advanced HER2-positive, HER2-low, or HER2-ultralow breast cancer, and to collect information on how patients feel.

Will I get a new or experimental treatment in this study?

No, you will receive trastuzumab deruxtecan (T-DXd) as part of your standard medical care; it is not an experimental drug in this study. The study simply observes how it works in real-life situations.

Will my doctors change my treatment because of this study?

No, the study does not define your treatment. Your doctor will make all decisions about your diagnosis, treatment, and how often you need to visit, based on what is best for your health.

What does 'HER2-positive, HER2-low, or HER2-ultralow' mean?

These terms describe the amount of a specific protein (HER2) found on your breast cancer cells, which helps doctors decide the best treatment approach for you.

What is a 'digital healthcare application'?

It's a computer program or app that can help you manage your health, such as tracking symptoms or providing health information. You will be informed about these during the study.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.