A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
This study is testing a new treatment combination for women with advanced, oestrogen receptor-positive (ER+), HER2-negative breast cancer. This type of breast cancer is often treated with hormone therapy, but if it has spread, more options are needed. The study is combining a new drug called H3B-6545 with a drug doctors already use called palbociclib. The main aim is to see how safe this combination is and to find the best dose to use in future studies. Researchers will be looking for any side effects and how well people tolerate the treatment. This is an early-stage study, meaning it's one of the first times this new combination is being tested in people.
En un coup d'œil
Résultats
Résultats de cette étude
Publié March 2024Les résultats de cette étude ont été publiés.
De quoi parle cette étude ?
This study is about helping women who have a specific type of advanced breast cancer. This cancer is called oestrogen receptor-positive (ER+) and HER2-negative. This means the cancer cells grow in response to the female hormone oestrogen, but they don't have too much of a protein called HER2. When breast cancer has spread, it's called advanced or metastatic, and doctors are always looking for better ways to treat it and keep it under control.
The study is testing a new drug, H3B-6545, alongside a drug that's already used, called palbociclib. Palbociclib works by stopping cancer cells from growing. H3B-6545 is a newer drug that aims to do something similar, but in a different way. The hope is that by combining these two drugs, they might work even better together to fight the cancer.
The main purpose of this study is to find out if this drug combination is safe and what the right dose should be. This step is really important because it helps doctors understand how a new treatment affects people before using it more widely. If the combination is found to be safe and manageable, it could pave the way for bigger studies to see how well it actually treats the cancer.
Points clés
- New drug H3B-6545 combined with existing drug palbociclib.
- For women with ER+ HER2- advanced or metastatic breast cancer.
- Main aim is to find a safe dose and understand side effects.
- It's an early-stage study (Phase 1).
- Requires previous treatment for advanced breast cancer.
- Participation involves regular clinic visits and taking oral medication.
Qui peut être éligible ?
To join this study, women need to have breast cancer that is oestrogen receptor-positive (ER+) and HER2-negative, which has either spread locally or to other parts of the body. You would also need to have received previous treatment for your advanced breast cancer. On top of that, your general health would need to be good enough to take part, meaning your body is working fairly well, and you can generally carry out your day-to-day activities.
There are also some reasons why you wouldn't be able to join. For example, if you currently have a serious infection that isn't under control, or if you've had major surgery or other specific cancer treatments very recently (within the last 4 weeks). People who can't take medicines by mouth, or have serious heart problems, or have active issues with alcohol or drug misuse would also not be able to participate. The study is for women aged 18 or older.
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.
- Do you have ER+ HER2- breast cancer that has spread?
- Have you already had treatment for your advanced breast cancer?
- Are you generally well enough to go about your daily life?
- Do you not have an active serious infection, serious heart problems, or issues that stop you from taking oral medicines?
- Avez-vous 18 ans ou plus ?
En quoi consiste la participation ?
If you join this study, it would involve regular visits to the clinic for check-ups and assessments. You would be given the study drugs, H3B-6545 and palbociclib, which are taken by mouth (as tablets or capsules). The dose of these drugs would be carefully monitored. You would need to have blood tests regularly, and doctors would check your general health, including how your organs are working. They would also ask about any side effects you might be experiencing. The exact number of visits and the total length of time you'd be involved can vary, but studies like this typically involve frequent checks initially, followed by less frequent visits if the treatment is stable. You would remain in the study as long as the treatment is helping you and you are tolerating it well.
Risques et avantages potentiels
Emplacements (8)
- Florida Cancer Specialists South - SCRI - PPDSCode postal vérifiéSarasota, United States
- Hôpital Général du MassachusettsCode postal vérifiéBoston, États-Unis
- Saint Luke's Cancer InstituteCode postal vérifiéKansas City, États-Unis
- Comprehensive Cancer Centers of NevadaCode postal vérifiéLas Vegas, United States
- Tennessee Oncology, PLLC - SCRI - PPDSCode postal vérifiéNashville, United States
- Royal Marsden NHS Foundation TrustCode postal vérifiéLondres, Royaume-Uni
- Sarah Cannon Research Institute UK - SCRICode postal vérifiéLondres, Royaume-Uni
- Royal Marsden NHS Foundation TrustCode postal vérifiéSutton, United Kingdom
Questions fréquentes
What is 'oestrogen receptor-positive' breast cancer?
This means your breast cancer cells grow when they are exposed to oestrogen, a female hormone. Treatments for this type of cancer often involve blocking oestrogen.
What does 'HER2-negative' mean?
HER2 is a protein. If your cancer is HER2-negative, it means your cancer cells don't have too much of this protein, so treatments that target HER2 wouldn't be effective.
Why are two drugs being used together?
Doctors hope that combining two different drugs might make the treatment more effective at fighting the cancer than using just one drug alone.
Est-ce un nouveau traitement ?
Palbociclib is an existing drug, but H3B-6545 is a new drug, and this is an early study to see how safe the combination is.
Quel est l'objectif principal de cette étude ?
The main goal is to find a safe dose of the combination treatment and understand any side effects, rather than to see if it cures the cancer at this early stage.
Comment en savoir plus
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Discussion
Discussion communautaire
Propulsé par notre forum à community.patient.info. Veuillez être respectueux — ceci n'est pas un avis médical.