Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)
This research study is testing a new medicine called patritumab deruxtecan for a specific type of breast cancer. This cancer is known as HER2-positive and has either spread to other parts of the body or cannot be removed with an operation. The main goals are to find out if this new medicine is safe, what side effects people might experience, and if it helps to shrink or even make the cancer disappear. Other existing anti-cancer medicines like Trastuzumab and Pertuzumab might also be used. The study is open to both men and women aged 18 and over in several countries, including the UK. It's an early-stage study, meaning researchers are still learning a lot about the treatment.
At a glance
What is this study about?
This study is exploring a new treatment called patritumab deruxtecan for people with HER2-positive breast cancer. HER2-positive means the cancer cells have a lot of a certain protein called HER2 on their surface, which can help the cancer grow. In this study, they are looking at breast cancer that has spread to other parts of the body (called metastatic) or has grown into nearby tissues and cannot be surgically removed (called unresectable locally advanced). These are situations where current treatments might not be as effective, so finding new options is very important.
The main aim of this research is to see how safe the new treatment, patritumab deruxtecan, is and how well people tolerate it, meaning what side effects they might experience. They also want to understand if this new medicine can make the cancer smaller or even make it go away. This is important because if the cancer shrinks or stops growing, it can improve a person's health and quality of life.
This study will involve different groups of people, some of whom have already tried certain anti-HER2 treatments. This helps researchers understand how the new medicine works in different situations and whether it can be an option when other treatments haven't worked as well. The information gathered from this study will help doctors learn more about how to best treat HER2-positive breast cancer in the future.
Key takeaways
- This study is for HER2-positive breast cancer that has spread or can't be surgically removed.
- It's testing a new medicine called patritumab deruxtecan to see if it's safe and effective.
- Participants will be closely checked for side effects and how their cancer responds.
- Some people may have tried other HER2 treatments before joining.
- You must be 18 or older and meet certain health criteria to take part.
Who may be eligible?
For this study, you need to have breast cancer that has been identified as HER2-positive. This cancer must also be a type that cannot be removed by surgery or has spread to other parts of your body. You should be generally healthy apart from your cancer, meaning your body is coping well with daily activities, and you don't have severe medical conditions like uncontrolled heart problems or serious lung disease.
Depending on which part of the study you might join, you may have already received a certain number of previous anti-HER2 treatments. Some parts of the study are for people who have already had a specific treatment called trastuzumab deruxtecan (T-DXd) and whose cancer has started to grow again afterwards. Other parts are for people who have had fewer previous treatments.
Certain health conditions would prevent someone from joining, such as specific heart conditions, a history of certain lung problems (like an inflammation of the lungs that needed treatment), active serious infections, or specific eye conditions. Also, you must be 18 years or older, and your doctors will check if any other health conditions you have would make it unsafe for you to participate.
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 I have HER2-positive breast cancer?
- Has my breast cancer spread or is it not able to be removed by surgery?
- Am I generally feeling well enough to manage daily activities?
- Do I have any serious heart or lung conditions that are not well-controlled?
- Have I had a specific treatment called trastuzumab deruxtecan (T-DXd) recently?
- Am I at least 18 years old?
What does participation involve?
Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would receive the study medication, patritumab deruxtecan, or potentially other existing anti-cancer medicines mentioned. The doctors and nurses would perform various health checks, including blood tests, scans, and physical examinations, to monitor your health and how the treatment is affecting you and your cancer. They will be looking for any side effects and checking if the treatment is working.
The exact number and timing of visits and assessments will be explained in detail by the study team, as it can vary depending on which part of the study you are in. You will be closely monitored throughout the treatment period and for a follow-up period afterwards. The total duration of your involvement in the study will also depend on your individual response to the treatment and the study plan, but detailed information will be provided before you decide to join.
Potential risks and benefits
Locations (18)
- University of Colorado Anschutz Medical Campus ( Site 0057)Verified postcodeAurora, United States· Recruiting
- Dana-Farber Cancer Institute ( Site 0050)Verified postcodeBoston, United States· Recruiting
- Rutgers Cancer Institute of New Jersey ( Site 0052)Verified postcodeNew Brunswick, United States· Recruiting
- Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)Verified postcodeGreenville, United States· Recruiting
- Inova Schar Cancer Institute ( Site 0051)Verified postcodeFairfax, United States· Recruiting
- Kingston General Hospital ( Site 0061)Verified postcodeKingston, Canada· Recruiting
- Princess Margaret Cancer Centre ( Site 0001)Verified postcodeToronto, Canada· Recruiting
- Centre Hospitalier de l'Université de Montréal ( Site 0004)Verified postcodeMontreal, Canada· Recruiting
- Jewish General Hospital ( Site 0003)Verified postcodeMontreal, Canada· Recruiting
- Rambam Health Care Campus ( Site 0011)Verified postcodeHaifa, Israel· Recruiting
- Rabin Medical Center ( Site 0012)Verified postcodePetah Tikva, Israel· Recruiting
- Sheba Medical Center ( Site 0010)Verified postcodeRamat Gan, Israel· Recruiting
Common questions
What is HER2-positive breast cancer?
HER2-positive breast cancer means the cancer cells have a lot of a protein called HER2 on their surface, which can help them grow quickly.
What does 'unresectable' and 'metastatic' mean?
'Unresectable' means the cancer cannot be removed with surgery. 'Metastatic' means the cancer has spread from the original site to other parts of the body.
Is patritumab deruxtecan a new drug?
Yes, patritumab deruxtecan is an investigation drug, meaning it's still being studied to see if it's safe and effective.
Will I definitely get the new drug?
The study involves different groups, and while some will receive patritumab deruxtecan, others might receive established treatments. Your doctor can explain the details specific to your situation.
Where is this study taking place?
This study is taking place in several countries, including the United Kingdom, Canada, USA, Israel, Japan, and South Korea.
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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