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Active not recruitingPHASE1INTERVENTIONAL

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.

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
Eisai Inc.
Enrolment target
31
Start
01 Apr 2020
Estimated completion
31 Mar 2027

Results

Results from this study

Posted March 2024

Results have been published for this study.

Primary outcome
Maximum Tolerated Dose (MTD) of H3B-6545 and Palbociclib
The MTD was defined as the highest dose at which no more than 1 of 6 participants experienced a Dose-Limiting Toxicity (DLT) in the dose cohort. DLT was graded as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. DLTs were defined as the following events that occurred in Cycle 1, for which a causal relationship with the study drug could not be ruled out: febrile neutropenia; Grade 4 neutropenia that was not resolved within 7 days; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia lasting greater than (\>) 7 days or associated with clinically significant bleeding; Grade 4 vomiting and diarrhea; Grade 3 vomiting and diarrhea lasting \> 72 hours despite treatment; Grade 4 electrolyte abnormality or Grade 3 abnormality lasting \> 24 hours; Grade 3 or 4 serum creatinine or bilirubin increase; Grade 4 biochemistry or Grade 3 lasting \> 7 days; Grade 4 or Grade 3 or intolerable grade 2 toxicities of any non-hematologic adverse event.
Full results on the registry

What is this study about?

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.

Key takeaways

  • 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.

Who may be eligible?

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.

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.

  1. Do you have ER+ HER2- breast cancer that has spread?
  2. Have you already had treatment for your advanced breast cancer?
  3. Are you generally well enough to go about your daily life?
  4. Do you not have an active serious infection, serious heart problems, or issues that stop you from taking oral medicines?
  5. Are you 18 years old or older?
Answer every question to see your result.

What does participation involve?

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.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment combination that could help manage your cancer, possibly better than standard treatments currently available. However, because H3B-6545 is a new drug, there might be side effects that are not yet fully known. Palbociclib also has known side effects, which doctors would explain to you. It's important to remember that safety is the main goal of this early study, and there's no guarantee the treatment will help your cancer. You would be closely monitored, and you have the right to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (8)

  • Florida Cancer Specialists South - SCRI - PPDS
    Verified postcode
    Sarasota, United States
  • Massachusetts General Hospital
    Verified postcode
    Boston, United States
  • Saint Luke's Cancer Institute
    Verified postcode
    Kansas City, United States
  • Comprehensive Cancer Centers of Nevada
    Verified postcode
    Las Vegas, United States
  • Tennessee Oncology, PLLC - SCRI - PPDS
    Verified postcode
    Nashville, United States
  • Royal Marsden NHS Foundation Trust
    Verified postcode
    London, United Kingdom
  • Sarah Cannon Research Institute UK - SCRI
    Verified postcode
    London, United Kingdom
  • Royal Marsden NHS Foundation Trust
    Verified postcode
    Sutton, United Kingdom

Common questions

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.

Is this a new treatment?

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.

What is the main goal of this study?

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.

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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