Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer
This study is investigating a new medication called zelenectide pevedotin (BT8009) for people with advanced breast cancer. It's for individuals whose cancer has started to grow again, can't be removed by surgery, or has spread to other parts of the body, and who have a specific marker called NECTIN4 in their cancer cells. The study is split into two groups: one for a type of breast cancer called HR+/HER2- negative, and another for Triple-Negative Breast Cancer (TNBC). Researchers want to see how effective and safe this new drug is. Participants must have already received some other treatments for their cancer. This is a worldwide study that is open to participants and doctors will know which treatment is being given.
At a glance
What is this study about?
This study is testing a new drug called zelenectide pevedotin (sometimes called BT8009) for people with advanced breast cancer. Advanced cancer means it has either come back after treatment, can't be removed by surgery, or has spread to other parts of the body. The goal of this research is to understand how well this new drug works and if it's safe to use.
What's special about this study is that it's for people whose cancer cells have a particular feature called 'NECTIN4 amplification'. This means there's a higher amount of the NECTIN4 gene in their cancer. The study will look at two main groups of breast cancer: one type called hormone receptor positive/HER2-negative breast cancer (HR+/HER2-), and another called triple-negative breast cancer (TNBC).
Researchers are particularly interested in people who have already had other treatments for their advanced breast cancer. By joining this study, you would help doctors learn more about this potential new medicine and how it could help people with specific types of advanced breast cancer in the future.
Key takeaways
- Tests a new drug, zelenectide pevedotin, for advanced breast cancer.
- Specifically targets cancer with a marker called NECTIN4.
- Includes HR+/HER2- and Triple-Negative Breast Cancer patients.
- Requires previous treatments for advanced cancer.
- Aims to assess the drug's effectiveness and safety.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, your doctors first need to check a sample of your cancer tissue (either an old sample or a new one) to see if it has the specific 'NECTIN4 amplification'. This is a key requirement. You also need to have cancer that can be measured, meaning doctors can track its size and changes. Your general health should be good enough to participate, with a life expectancy of at least 12 weeks, and you should be able to perform your usual daily activities without too much difficulty.
For those with HR+/HER2- negative breast cancer, you should have already tried at least one, but no more than three, other treatments for your advanced cancer that were not hormone-based. If you have triple-negative breast cancer, you also need to have received at least one, but no more than three, previous treatments for your advanced cancer. This includes some cases where the cancer is 'ER-low positive'.
There are also some reasons why you wouldn't be able to join. For instance, if you've already had a similar type of drug called an 'antibody drug conjugate' that contained a specific chemical called MMAE. You also can't be allergic to any ingredients in the study drug. Other reasons might include certain eye conditions, active cancer that has spread to your brain or spinal cord, uncontrolled diabetes or high blood pressure, or serious lung problems. Your doctors will review all these points carefully to see if this study is right for you.
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.
- Has my doctor confirmed I have advanced HR+/HER2- or Triple-Negative Breast Cancer?
- Do my cancer cells have the NECTIN4 marker?
- Have I had at least 1, but no more than 3, previous treatments for my advanced cancer?
- Do I generally feel well and able to carry out daily activities?
- Do I have any specific health conditions that might prevent participation (such as certain eye problems or uncontrolled diabetes)?
- Have I previously had a similar drug called an antibody drug conjugate (ADC) with an MMAE component?
What does participation involve?
If you decide to take part in this study, you will receive the study drug, zelenectide pevedotin, as part of your treatment. The study is 'open-label', which means both you and your doctors will know you are receiving this specific drug. You will have regular visits to the clinic for check-ups, blood tests, and scans to see how the treatment is working and to monitor your health. The duration of your participation will depend on how you respond to the treatment and the study plan, but you will be monitored closely throughout. Specific details about the frequency of visits and tests will be discussed thoroughly by the study staff.
Potential risks and benefits
Locations (18)
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC)Verified postcodeBaltimore, United States
- Dana-Farber Cancer InstituteVerified postcodeBoston, United States
- Siteman Cancer CenterVerified postcodeSt Louis, United States
- Memorial Sloan Kettering Cancer Center - Main CampusVerified postcodeNew York, United States
- Duke Cancer InstituteVerified postcodeDurham, United States
- Compass Oncology - Rose Quarter Cancer CenterVerified postcodePortland, United States
- Texas Oncology San AntonioVerified postcodeSan Antonio, United States
- Virginia Cancer SpecialistsVerified postcodeFairfax, United States
- Peter MacCallum Cancer CentreVerified postcodeMelbourne, Australia
- UZ LeuvenVerified postcodeLeuven, Belgium
- Oncopole Claudius RegaudVerified postcodeToulouse, France
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS IRSTVerified postcodeMeldola, Italy
Common questions
What is NECTIN4 amplification?
NECTIN4 amplification means your cancer cells have more of a specific genetic marker called NECTIN4. This study is focused on drugs that target this marker.
What does 'advanced breast cancer' mean in this study?
It means the cancer has returned, cannot be removed by surgery, or has spread to other parts of the body.
Will I know if I'm getting the study drug?
Yes, this is an 'open-label' study, so both you and your doctor will know that you are receiving the study drug, zelenectide pevedotin.
Can I stop participating in the study if I want to?
Yes, you can choose to leave the study at any time, for any reason, and it will not affect your ongoing medical care.
What types of breast cancer are included?
The study includes two main types: hormone receptor positive/HER2-negative (HR+/HER2-) and triple-negative breast cancer (TNBC).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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