Active not recruitingPHASE3INTERVENTIONAL

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

This study is looking at a new medicine called trastuzumab deruxtecan (also known as DS-8201a) to treat a specific type of breast cancer. It's for people whose breast cancer has 'low' levels of a protein called HER2. This cancer must also have spread to other parts of the body or can't be removed with an operation. Participants would have already tried other treatments that are no longer working. The study aims to see if the new drug is safer and works better than standard treatments currently chosen by doctors. It's a large-scale study involving many people and is an important step in potentially offering a new treatment option.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Daiichi Sankyo

Enrolment target

557

Start

27 Dec 2018

Estimated completion

01 Aug 2026

Breast Cancer

Results

Results from this study

Posted June 2023

Results have been published for this study.

Primary outcome

Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer

Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method.

Full results on the registry

What is this study about?

This study, called DESTINY-Breast04, is testing a new drug named trastuzumab deruxtecan (or DS-8201a) for people with a particular kind of breast cancer. Doctors describe this cancer as 'HER2-low', which means the cancer cells have small amounts of a protein called HER2 on their surface. This is different from HER2-positive cancer, which has much higher levels.

The study is for people whose breast cancer has grown or spread beyond the original site (called metastatic breast cancer) or cannot be removed by surgery (unresectable). Importantly, participants will have already received other treatments for their cancer that are no longer effective. The researchers want to find out if this new drug is a better option than the standard treatments doctors would usually choose for this group of patients.

By comparing the new drug with existing treatments, the study hopes to discover if it can help people live longer, improve their quality of life, or shrink their tumours more effectively. This research is crucial because it could lead to a new approved treatment for breast cancer patients who currently have limited options.

Key takeaways

This study compares a new drug (trastuzumab deruxtecan) with standard treatments for breast cancer.
It's for people with 'HER2-low' breast cancer that has spread or cannot be removed by surgery.
Suitable participants have already received other cancer treatments.
You would be randomly assigned to receive either the new drug or a standard treatment.
The study aims to find out if the new drug is safer and works better.

Who may be eligible?

To join this study, you generally need to be an adult (age of majority in your country) and have breast cancer that is 'HER2-low'. This means specific tests on your cancer cells confirm low levels of the HER2 protein. Your cancer must have either spread to other parts of your body, or doctors have said it cannot be removed with surgery.

You would have already tried one or two types of chemotherapy for your advanced breast cancer. It's also important that your cancer has previously been shown *not* to be HER2-positive (high HER2 levels). You will also need to have generally good organ function, including your heart, kidneys, and liver.

There are also reasons why you might not be able to join. For example, if you've ever had breast cancer with high HER2 levels, or if you've already received similar anti-HER2 treatments. Certain heart conditions, active brain tumours, or specific lung problems (like interstitial lung disease) would also prevent you from participating.

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 an adult (over 18 years old)?
Do you have breast cancer that is 'HER2-low'?
Has your cancer spread to other parts of your body or can it not be removed by surgery?
Have you already had 1 to 2 chemotherapy treatments for your advanced cancer and they are no longer working?
Do you have generally good heart, kidney, and liver function?
Have you *never* been diagnosed with HER2-positive breast cancer in the past?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first undergo checks to ensure you meet all the requirements. This might include reviewing your medical history, having blood tests, and imaging scans (like X-rays or CT scans) to assess your cancer. You might also need to provide a new tissue sample (biopsy) of your tumour, or the doctors will use an existing sample.

If you qualify, you will be randomly assigned to receive either the new drug, trastuzumab deruxtecan, or one of the standard chemotherapy treatments that your doctor would normally consider. You wouldn't get to choose which treatment you receive; it's decided by chance, like flipping a coin. You will have regular clinic visits for your treatment and to monitor how you're feeling and how your cancer is responding. These visits will involve physical exams, blood tests, and imaging scans. The exact number of visits and their duration will depend on how your treatment progresses, but the study will involve ongoing check-ups for as long as the treatment is beneficial or until side effects make it necessary to stop. There will also be follow-up checks after you stop treatment. Both men and women will need to use effective contraception during the study and for several months afterward.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new drug that might be more effective than current treatments for your specific type of cancer. You will also receive very close medical monitoring throughout the study. However, there are also potential risks. The new drug, or even the standard treatments, may cause side effects, some of which could be serious or unexpected. Researchers are always careful to manage and report these side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (208)

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

Ironwood Cancer & Research Centers - Chandler II
Verified postcode
Chandler, United States
Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States
Cancer Treatment Centers of America at Western Regional Medical Center
Verified postcode
Goodyear, United States
UCLA School of Medicine
Verified postcode
Los Angeles, United States
Stanford Cancer Institute
Verified postcode
Palo Alto, United States
Cancer Care Associates Medical Group, Inc. TORI
Verified postcode
Redondo Beach, United States
University of California at San Francisco (PARENT)
Verified postcode
San Francisco, United States
Eastern Connecticut Hematology/Oncology Assoc.
Verified postcode
Norwich, United States
Christiana Care Health Services, Inc.
Verified postcode
Newark, United States
Sylvester Comprehensive Cancer Center - Deerfield Beach
Verified postcode
Boca Raton, United States
Florida Cancer Specialists (South Region)
Verified postcode
Fort Myers, United States
Memorial Healthcare System MRH Cancer Center
Verified postcode
Hollywood, United States

Common questions

What does 'HER2-low' mean?

HER2-low breast cancer means that tests show a small amount of the HER2 protein on your cancer cells, but not enough to be called HER2-positive.

What is trastuzumab deruxtecan?

It's a new experimental drug being tested to treat HER2-low breast cancer that has spread or can't be surgically removed.

Why is this study important?

It could potentially provide a new and more effective treatment option for people with HER2-low breast cancer who have already tried other therapies.

Will I definitely get the new drug?

No, you will be randomly assigned to either receive the new drug or one of the standard treatments chosen by your doctor. It's like drawing lots.

What happens if the treatment stops working?

Your doctors will regularly monitor your cancer. If the treatment is no longer helpful or side effects become too severe, you will stop the study treatment and discuss other options with your care team.