CT7001_002 (SUMIT-BC) - An open-label Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant with or without Samuraciclib in Participants with Metastatic or Locally Advanced Hormone Receptor Positive and Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
This study, called SUMIT-BC, is for people in the UK with advanced breast cancer that has spread to other parts of the body (metastatic) or is locally advanced. This type of cancer is sensitive to hormones and isn't HER2-positive. We are testing a new treatment called Samuraciclib alongside a common treatment called Fulvestrant. Fulvestrant is given as an injection, and Samuraciclib is a tablet. The main goal is to see if this combination causes a 'clinical benefit response,' which means the cancer shrinks, disappears, or stays stable for at least 24 weeks. We'll also look at side effects, how long people stay well without their cancer getting worse, and how many people's cancer shrinks.
En un coup d'œil
De quoi parle cette étude ?
This research study, known as SUMIT-BC, is a Phase 2 clinical trial. This means it's an important step where we test a new treatment combination in a larger group of people to see how well it works and if it's safe.
The study is specifically for people who have breast cancer that has either spread to other parts of the body (called metastatic) or is locally advanced. This type of breast cancer is also 'hormone receptor positive,' meaning its growth is encouraged by hormones, and 'HER2 negative,' meaning it doesn't have too much of a protein called HER2. We are comparing two groups: one group will receive a standard treatment called Fulvestrant (given as an injection) by itself, and the other group will receive Fulvestrant along with a new investigational drug called Samuraciclib (which is a tablet).
The main aim of the study is to find out if adding Samuraciclib to Fulvestrant helps more people achieve a 'clinical benefit response.' This means we want to see if the cancer shrinks, disappears completely, or stays stable and doesn't get worse for at least 24 weeks (about six months). We will also carefully monitor any side effects people experience, how long people live without their cancer getting worse, and how often the cancer shrinks or disappears.
Points clés
- Tests a new breast cancer drug, Samuraciclib, with an existing one, Fulvestrant.
- For advanced, hormone-positive, HER2-negative breast cancer.
- Studies if the new combination can help control cancer for longer.
- Participation involves regular appointments, blood tests, and scans.
- Vous pouvez arrêter de participer à tout moment.
- It's a Phase 2 study, meaning the treatment is still in development.
Qui peut être éligible ?
To be considered for this study, you need to be at least 18 years old and have breast cancer that is either locally advanced (meaning it has grown into nearby tissues but hasn't spread far) or metastatic (meaning it has spread to other parts of your body).
Your breast cancer must also be 'hormone receptor positive,' which means its growth is linked to hormones, and 'HER2 negative,' meaning it doesn't have an excess of a specific protein called HER2. Both men and women can potentially take part in this study. There will be other specific medical criteria that your doctor will check to see if this study is right for you.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- Avez-vous au moins 18 ans ?
- Do you have breast cancer that is locally advanced or has spread (metastatic)?
- Is your breast cancer hormone receptor positive?
- Is your breast cancer HER2 negative?
En quoi consiste la participation ?
If you decide to take part in this study, you would receive either the standard breast cancer treatment called Fulvestrant (given as an injection) or Fulvestrant combined with the new investigational tablet, Samuraciclib. You won't be able to choose which treatment group you are in; this will be decided by chance, like flipping a coin.
Throughout the study, you would have regular hospital visits for assessments. These visits will involve blood tests, physical examinations, and scans (like CT scans) to check how the treatment is working and to monitor your health. Your doctor and the study team will explain exactly how often these visits will be and for how long. The total duration of your participation will depend on how you respond to the treatment and will be discussed with you in detail.
Risques et avantages potentiels
Emplacements (2)
- —Non vérifiéEspagne
- —Non vérifiéHongrie
Questions fréquentes
What kind of breast cancer is this study for?
This study is for advanced breast cancer that has spread or grown locally, which is sensitive to hormones and is not HER2-positive.
What is Fulvestrant?
Fulvestrant is a common medication for hormone-sensitive breast cancer, given as an injection.
What is Samuraciclib?
Samuraciclib is a new, investigational drug in tablet form that is being tested in this study.
Saurai-je quel traitement je reçois ?
No, you will be put into one of the treatment groups randomly, so neither you nor your doctor will get to choose.
What does 'clinical benefit response' mean?
It means the cancer shrinks, disappears, or stays stable without getting worse for at least 24 weeks.
Comment en savoir plus
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Intéressé à participer ?
Discussion
Discussion communautaire
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