A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
This study explores a new treatment called patritumab deruxtecan for breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-). This type of cancer has either spread locally and cannot be removed by surgery, or has spread to other parts of the body (metastatic). Researchers want to find out if patritumab deruxtecan is more effective than current treatments like chemotherapy or trastuzumab deruxtecan. The main goal is to see if patients live longer overall or if the cancer takes longer to grow or spread with the new drug. It's for people whose cancer has progressed after previous treatments.
At a glance
What is this study about?
This study is investigating a new medication called patritumab deruxtecan for a specific type of breast cancer. This cancer is described as 'hormone receptor-positive' (meaning its growth is affected by hormones like oestrogen or progesterone) and 'HER2-negative' (meaning it has low levels of a protein called HER2). The cancer has either spread too much locally to be removed by surgery, or it has spread to other parts of the body, which is called metastatic cancer.
Currently, people with this type of advanced breast cancer typically receive hormone therapy, sometimes combined with other treatments. However, if the cancer continues to grow or comes back, further options are needed. This study aims to see if patritumab deruxtecan can offer a better outcome compared to existing treatments like chemotherapy or another drug called trastuzumab deruxtecan.
The main purpose of this research is to discover if people taking patritumab deruxtecan live longer, or if the time before their cancer grows or spreads is extended, compared to those receiving the standard treatments. By finding new and more effective ways to manage advanced breast cancer, researchers hope to improve the lives of patients.
Key takeaways
- The study is for a specific type of advanced breast cancer (HR+/HER2-).
- It tests a new drug, patritumab deruxtecan, against current treatments.
- The main goal is to see if the new drug helps people live longer or stops cancer growth.
- Participants will be randomly assigned to receive either the new drug or a standard treatment.
- You must have already received previous treatments for your advanced breast cancer.
Who may be eligible?
To join this study, you must have advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-). This means your cancer cannot be removed by surgery because it has grown too much locally, or it has spread to other parts of your body. Your cancer must have been confirmed to have these specific features by tests, including looking at levels of another protein called HER3.
You must have already received certain treatments for your advanced breast cancer. Specifically, your cancer must have grown or come back after you had an earlier type of hormone therapy combined with a CDK4/6 inhibitor. This could have happened either during your first treatment for advanced cancer, or within two years of finishing a similar treatment after earlier surgery.
Other important requirements include being at least 18 years old, having cancer that can be measured, and generally being well enough to take part. There are also specific medical conditions, like certain other cancers or not being able to receive further hormone-based treatment, that would prevent you from joining.
- Do you have advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-)?
- Has your breast cancer either spread locally and cannot be surgically removed, or has it spread to other parts of your body?
- Has your cancer progressed or returned after you've previously received hormone therapy combined with a CDK4/6 inhibitor?
- Are you at least 18 years old?
- Are you generally well enough to participate in a clinical study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
Taking part in this study would involve regular hospital visits for assessments and to receive the study medication. You would receive either the new drug, patritumab deruxtecan, or one of the standard treatments for your condition. This would be decided randomly, like flipping a coin. You would have blood tests, scans, and physical examinations to closely monitor your health and how the treatment is working. We cannot provide a total duration, but you would continue treatment and monitoring for as long as it is safe and beneficial for you, or until the study requires follow-up. Detailed information on visits and assessments would be given by the study team.
Potential risks and benefits
Locations (181)
- Southern Cancer Center (SCC) ( Site 8000)Daphne, United States· Recruiting
- The University of Arizona Cancer Center - North Campus ( Site 0055)Tucson, United States· Recruiting
- Los Angeles Hematology Oncology Medical Group ( Site 0026)Los Angeles, United States· Recruiting
- Hoag Memorial Hospital Presbyterian ( Site 0025)Newport Beach, United States· Recruiting
- St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 0021)Grand Junction, United States· Recruiting
- Medical Oncology Hematology Consultants (MOHC) ( Site 8002)Newark, United States· Recruiting
- Comprehensive Hematology Oncology ( Site 0060)St. Petersburg, United States· Recruiting
- Baptist Health Lexington ( Site 0050)Lexington, United States· Recruiting
- Baptist Health Hamburg ( Site 0071)Lexington, United States· Recruiting
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)Hackensack, United States· Recruiting
- Rutgers Cancer Institute of New Jersey ( Site 0033)New Brunswick, United States· Recruiting
- Presbyterian Kaseman Hospital ( Site 0072)Albuquerque, United States· Recruiting
+169 more sites — see the official record for the full list.
Common questions
What kind of breast cancer is this study for?
This study is for a specific type of advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-), and has either spread locally or to other parts of the body.
What is patritumab deruxtecan?
It is a new medication being tested to see if it can help treat this specific type of advanced breast cancer. Its other names are HER3-DXd and MK-1022.
Will I definitely get the new drug?
Not necessarily. Study participants are randomly assigned to receive either the new drug or one of the standard treatments. You wouldn't be able to choose.
What does 'unresectable locally advanced' mean?
It means the cancer has spread into nearby tissues or muscles but cannot be completely removed by surgery.
What does 'metastatic' mean?
Metastatic means the cancer has spread from the original site in the breast to other parts of the body.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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