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.
Em resumo
Resultados
Resultados deste estudo
Publicado March 2024Os resultados foram publicados para este estudo.
Sobre o que é este estudo?
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.
Pontos principais
- 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.
Quem pode ser elegível?
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.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- 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?
- Você tem 18 anos ou mais?
O que envolve a participação?
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.
Riscos e benefícios potenciais
Locations (8)
- Florida Cancer Specialists South - SCRI - PPDSCódigo postal verificadoSarasota, Estados Unidos
- Hospital Geral de MassachusettsCódigo postal verificadoBoston, Estados Unidos
- Saint Luke's Cancer InstituteCódigo postal verificadoKansas City, Estados Unidos
- Comprehensive Cancer Centers of NevadaCódigo postal verificadoLas Vegas, United States
- Tennessee Oncology, PLLC - SCRI - PPDSCódigo postal verificadoNashville, Estados Unidos
- Royal Marsden NHS Foundation TrustCódigo postal verificadoLondres, Reino Unido
- Sarah Cannon Research Institute UK - SCRICódigo postal verificadoLondres, Reino Unido
- Royal Marsden NHS Foundation TrustCódigo postal verificadoSutton, United Kingdom
Perguntas frequentes
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.
Este é um novo tratamento?
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.
Qual é o principal objetivo deste estudo?
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.
Como saber mais
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
Discussão
Discussão da comunidade
Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.