Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1b/2 Open-Label Study of Samuraciclib in Combination with Elacestrant in Participants with Metastatic or Locally Advanced Hormone-Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer

This research study is about testing a new combination of two drugs, samuraciclib and elacestrant, for people with breast cancer that has spread or is locally advanced. This type of breast cancer is hormone-sensitive and does not have too much of a protein called HER2. The study has two main parts. The first part aims to find the safest and most effective dose for these two drugs when used together. The second part will then use this dose to further check how well the drugs work to shrink or control the cancer and how safe they are for patients. The overall goal is to find better treatment options for this specific type of breast cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Carrick Therapeutics Limited

Enrolment target

Start

25 Sep 2023

Breast Cancer

What is this study about?

This study is looking into a new treatment approach for a specific type of breast cancer. This is breast cancer that is considered 'hormone-receptor-positive' (meaning its growth is fueled by hormones) and 'HER2-negative' (meaning it doesn't have a lot of a protein called HER2). This type of cancer has either spread to other parts of the body (metastatic) or is advanced in the area where it started.

The researchers are testing a combination of two medicines: samuraciclib and elacestrant (which is also known by the brand name ORSERDU). They want to see if using these two drugs together is more effective than current treatments. The study is divided into two main stages. The first stage, called Phase 1b, is about finding the right dose for the combination of these two drugs. This involves carefully increasing the dose to see what is safe and well-tolerated by patients, and identifying any side effects.

Once the best dose is found, the study moves into Phase 2. In this stage, more people will receive the drug combination at the selected dose. The main goal of this second stage is to see how long patients live without their cancer getting worse (this is called 'progression-free survival'). They will also carefully watch for any side effects and see how the cancer responds to the treatment.

Key takeaways

Tests a new combination of two drugs for a specific type of advanced breast cancer.
Aims to find the safest and most effective dose.
Will assess how long the treatment controls the cancer.
Includes monitoring for side effects and how cancer responds.
Open to adults aged 18 or older, both men and women.
Might offer access to a new treatment approach.

Who may be eligible?

To be able to take part in this study, you must be an adult aged 18 years or older. Both men and women can participate.

You would need to have been diagnosed with breast cancer that is hormone-receptor-positive and HER2-negative. This means your cancer is driven by hormones, but doesn't have high levels of the HER2 protein. The cancer also needs to be advanced, either having spread to other parts of your body (metastatic) or being locally advanced, meaning it has grown significantly in the area where it started.

There will be other specific health requirements and medical tests that you would need to meet to ensure the study is safe and appropriate for you. Your doctor will be able to discuss these in more detail.

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 18 years old or over?
Do you have hormone-receptor-positive, HER2-negative breast cancer?
Has your breast cancer spread or is it locally advanced?
Are you comfortable taking medication in tablet form?
Are you willing to attend regular hospital visits for check-ups and tests?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for assessments. These visits would include check-ups, blood tests, and scans to monitor your health and how the treatment is working. You would be given the study medications, samuraciclib and elacestrant, which are film-coated tablets, to take as prescribed.

The initial part of the study (Phase 1b) focuses on finding the right dose, so your dose might be adjusted during this stage. In the second part (Phase 2), you would continue taking the medications at the chosen dose. The study will track how long it takes before your cancer shows signs of worsening or if new problems arise. Your health and any side effects will be closely monitored throughout your time in the study.

The total duration of your participation would depend on how long the treatment works for you and how you tolerate it. There will be follow-up appointments even after you stop taking the study medication to continue monitoring your health.

Potential risks and benefits

Participating in research studies like this can offer potential benefits, such as gaining access to new treatments before they are widely available. While the aim is to improve breast cancer treatment, there's no guarantee the new drugs will work for everyone, or that they will be better than standard treatments. As with all medications, there's a possibility of side effects, which the research team will closely monitor. These potential side effects are carefully assessed. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Spain

Common questions

What type of breast cancer is this study for?

This study is for breast cancer that is hormone-receptor-positive and HER2-negative, and has either spread (metastatic) or is locally advanced.

What are the drugs being tested?

The study is testing a combination of two drugs: samuraciclib and elacestrant (also known as ORSERDU).

Will I know which dose I'm getting?

In the first part of the study, the dose may be adjusted to find the safest and most effective level. In the second part, everyone will receive the selected dose.

What is the main goal of the study?

The main goal is to find out if the drug combination is safe, how well it works to control the cancer, and how long people live without their cancer getting worse.

Can men join this study?

Yes, both men and women aged 18 and over can take part in this study, provided they meet all other eligibility criteria.