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This study includes several steps and lasts about 208 days in total. It begins with a screening period that lasts 28 days. During this time, you will have a full physical exam, your medical history will be reviewed, and you will have routine lab tests, a heart test called an electrocardiogram, and a sensor placed to check your blood sugar levels. If you qualify and choose to join, you will be randomly assigned on the first dose day to receive either the study drug, called CNP-103, or a placebo, which does not contain any active medicine. The medicine or placebo will be given through a vein. The treatment period lasts 90 days, followed by another 90 days of follow-up. During this time, doctors will check how your body reacts to the medicine and how safe it is.

If you join this study, you will be placed into one of two groups by chance. Most people will take a daily pill called tirabrutinib. A smaller group will receive standard treatment with a medicine called rituximab through a vein and another medicine called temozolomide taken by mouth. Treatment happens in cycles that last 28 days. Some people may keep taking the treatment as long as it is helping and safe. During the study, you will have regular doctor visits, scans such as MRI, lab tests, and check ins to watch your health.

Everyone who shows interest and passes an early screening will be invited to join all three design group sessions. At the first session, the team will explain what the sessions are about, the benefits and risks, and ask people to give consent. They will also complete some short assessments. The total time for all three sessions will be about three hours, and the team will schedule them at times that work best for the doctors, patients, and caregivers taking part. All three sessions will be held online. In these sessions, doctors and patient or caregiver participants will help design and improve a new tool that supports medical decision making.

This study does not require much extra time from patients, but doctors will check on them closely for two years. People in the study are placed into groups by chance. Two out of every three people will get the new shoulder device, and one out of three will get the regular device that uses a stem.

We are building a database of people who would like to be contacted about future dermatology research studies. This is a way for people who are interested in participating in research opportunities to learn about a research study that they may not have otherwise known about.

Being in this study lasts up to ten months. After screening and joining, participants may choose to use the Minder device or receive regular epilepsy care only. People who choose the device will have a small brain monitoring device placed under the scalp. About two weeks later, they will receive a wearable device and a study phone. People using the device will then be placed by chance into one of two groups. In one group, the study doctor can look at the device information during the study. In the other group, the information is collected but not reviewed until the study is over. Everyone in the study will have follow up visits around one month and six months, answer questionnaires, review medicines, and track seizures. Some visits may happen by phone or video.

Taking part in this study can last up to two years after joining. People will have a first visit and then follow up visits every six months, for up to five visits total. These visits may happen in person, by phone, or by video. At each visit, the study team will check overall health, seizures, medicines, hospital stays, and any problems with the implanted device. They will also review information collected by the Minder device and ask people to answer questions about mood, memory, anxiety, and quality of life. Between visits, the study doctor may review device information each month as part of regular care. Some people may be asked to come in for extra visits if needed. No new surgery is required because the device was already placed before the study.

We are doing this study to test the safety and effectiveness of the study drug, datopotamab deruxtecan (also known as dato-DXd), and find out if it is a potential option for patients with metastatic breast cancer that has spread to the brain and/or spinal cord.