A Phase 2, Multi-Center, Randomized, Open-Label Trial of BDC-1001 as Single Agent and in Combination with Pertuzumab in Subjects with Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Previously Treated with Trastuzumab Deruxtecan
This clinical trial is looking at a new treatment called BDC-1001 for people with advanced breast cancer. This type of cancer is called HER2-positive, meaning it has a specific protein that helps cancer cells grow. The cancer has also spread to other parts of the body (metastatic) and has already been treated with a different medicine called trastuzumab deruxtecan. Researchers want to find out how effective BDC-1001 is at shrinking or stopping the cancer from growing. They are testing it both by itself and in combination with another approved cancer drug called pertuzumab. This is a Phase 2 study, which means it's still in the earlier stages of drug testing, following initial safety checks, to see if the treatment shows promise for patients.
At a glance
What is this study about?
This study is about finding better treatments for a type of breast cancer called HER2-positive metastatic breast cancer. 'HER2-positive' means the cancer cells have a lot of a protein called HER2, which helps them grow quickly. 'Metastatic' means the cancer has spread from the breast to other parts of the body. Unfortunately, cancer that has spread can be harder to treat, and it's essential to keep looking for new and effective options.
The patients in this study have already received a different treatment called trastuzumab deruxtecan. Researchers are now testing a new medicine called BDC-1001. They want to see how well BDC-1001 works on its own and when combined with another common cancer drug called pertuzumab. The main goal is to see if these treatments can shrink the cancer or stop it from growing.
Understanding how new treatments work is vital for improving patient care. By taking part in studies like this, patients contribute to medical knowledge that can help not only themselves but also others with HER2-positive breast cancer in the future. The information gathered will help doctors decide if BDC-1001 could become a new standard treatment option.
Key takeaways
- This study is testing a new drug, BDC-1001, for HER2-positive metastatic breast cancer.
- It's for people who have already been treated with trastuzumab deruxtecan.
- BDC-1001 is being tested alone and with another drug, pertuzumab.
- The main goal is to see if the treatment shrinks or stops cancer growth.
- You will have regular medical check-ups and tests if you participate.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. The study is specifically for people who have breast cancer that is HER2-positive and has spread to other parts of their body.
Importantly, you must have already been treated with a medicine called trastuzumab deruxtecan for your advanced breast cancer. The study doctors will need to check your medical history and conduct tests to make sure you meet all the specific requirements, as there are often other health conditions or previous treatments that might prevent someone from joining.
The research team will go through all the details with you to confirm if this study might be a suitable option for your unique situation.
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 at least 18 years old?
- Do you have HER2-positive breast cancer that has spread?
- Have you already received a medicine called trastuzumab deruxtecan for your advanced breast cancer?
- Are you able to attend regular clinic appointments for treatment and tests?
What does participation involve?
If you decide to take part in this study, you will receive either BDC-1001 by itself or BDC-1001 combined with pertuzumab. These medicines will be given as infusions (into a vein) at regular visits to the clinic.
Throughout the study, you will have regular check-ups, which include blood tests, physical exams, and scans (like CT scans) to see how the treatment is working and monitor your overall health. We will also monitor your vital signs, like blood pressure, and perform ECGs to check your heart.
Researchers will also take blood samples to measure the levels of the study drug in your body and check for any reactions to the medication. The total duration of your participation will depend on how you respond to the treatment, but you will stop treatment if your cancer gets worse or if you experience side effects that make continuing unsafe. Even after stopping the treatment, there will be follow-up appointments to monitor your health.
Potential risks and benefits
Locations (3)
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedItaly
Common questions
What does 'HER2-positive' mean?
It means your cancer cells have a lot of a specific protein called HER2, which can make the cancer grow faster. Treatments that target HER2 can be very effective.
What does 'metastatic' mean?
Metastatic means the cancer has spread from where it started (your breast) to other parts of your body. This is also sometimes called advanced cancer.
What is a 'Phase 2' study?
A Phase 2 study is a stage where researchers test a new drug on a larger group of patients to see if it's effective and to gather more information about its safety and side effects.
Will I get a placebo (dummy medicine)?
No, this study is 'open-label', which means everyone will know which active treatment they are receiving, and no one will receive a placebo.
What is trastuzumab deruxtecan?
It's an approved medicine used to treat HER2-positive breast cancer that has already spread. This study is for people who have already had this treatment.
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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