Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1b Trial of ARV-471 in Combination with Everolimus in Patients with ER+, HER2– Advanced or Metastatic Breast Cancer

This research is an early-stage clinical trial looking into a new treatment for a specific type of advanced breast cancer. The breast cancer must be "ER-positive" and "HER2-negative," meaning it responds to certain hormones but not others. The study combines two existing drugs, ARV-471 and Everolimus, which are given as tablets. The main aim is to carefully check for any side effects and find the right and safest dose to use in future studies. Researchers will also look at how patients’ bodies process the drugs and try to get an early idea of how effective the combination might be. This is a very early step in understanding if this treatment could help people with this kind of breast cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Arvinas Estrogen Receptor Inc.

Enrolment target

Start

17 Jul 2024

HER2– Advanced or Metastatic Breast Cancer

What is this study about?

This study is a Phase 1b clinical trial, which means it's an early stage of research where doctors are mainly focused on safety and finding the best dose of a new treatment combination. They are testing two medicines together: ARV-471 and Everolimus. This combination is being explored for people who have advanced breast cancer that has specific features – it's called 'ER-positive' (meaning its growth is driven by hormones like oestrogen) and 'HER2-negative' (meaning it doesn't have too much of a protein called HER2).

Advanced breast cancer means the cancer has either spread beyond the breast area or has come back after previous treatments. The purpose of this study is to see how safe the combination of ARV-471 and Everolimus is, what side effects it might cause, and to work out the most effective and tolerable dose to be used in future, larger studies. Researchers will be closely monitoring how patients respond to the treatment and tracking any changes in their health.

While this is an early study, the hope is that by combining these two drugs, it might offer a new way to treat this specific type of breast cancer. Understanding how the drugs work together, what side effects they cause, and finding the right dose are crucial steps before this treatment could potentially become widely available.

Key takeaways

This is an early-stage study checking a new two-drug combination for advanced breast cancer.
The cancer must be ER-positive and HER2-negative.
The main goals are to find a safe dose and understand side effects.
Participants will take two different medicines, ARV-471 and Everolimus.
Close medical monitoring for safety and response is a key part of participating.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women are welcome to participate if they meet the specific health requirements.

Critically, your breast cancer must be advanced, meaning it has spread to other parts of your body (metastatic) or has returned after previous treatments. It also needs to have specific characteristics: it must be 'ER-positive' (meaning it's sensitive to hormones) and 'HER2-negative' (meaning it doesn't have an excess of the HER2 protein).

The research team will carry out several tests and review your medical history to make sure this study is right for you and that you meet all the necessary criteria for joining. It's important to discuss your full medical history with the study doctors.

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 at least 18 years old?
Do you have advanced breast cancer that is ER-positive and HER2-negative?
Are you able to take medicines by mouth (tablets)?
Are you willing and able to attend regular clinic appointments for monitoring?

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. You would be given the study medications, ARV-471 and Everolimus, likely in tablet form, to take as directed. During your visits, doctors will perform physical examinations, take blood and urine samples, and ask you about any side effects you might be experiencing. They'll use these tests to monitor your health, check for side effects, and see how your body is responding to the treatment. The study will closely track any changes in your health and how the drugs are affecting you. The total duration of your participation will depend on how you respond to the treatment and the study plan, but it will involve ongoing assessments and follow-up.

Potential risks and benefits

As with any clinical trial, there are potential benefits and potential risks. You might benefit from a new treatment combination that could help manage your cancer, or you could simply contribute to medical knowledge that helps others in the future. However, there's no guarantee the treatment will work for you, and you might experience side effects. These could range from mild to severe, and the research team will monitor you closely for any issues. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What does 'ER-positive, HER2-negative' breast cancer mean?

It describes specific features of your cancer cells. 'ER-positive' means the cancer uses the hormone oestrogen to grow, and 'HER2-negative' means it doesn't have an excess of a protein called HER2. This helps doctors choose the right treatments.

What is a 'Phase 1b' study?

This is an early stage of research where doctors focus mainly on checking that a new treatment is safe and finding the best dose to use. It's not yet about whether the treatment works in lots of people.

Will I receive new medication?

Yes, you will receive a combination of two medications, ARV-471 and Everolimus, which are being tested together in this study.

What kind of side effects might I experience?

The study will closely monitor all side effects. These can vary greatly between individuals, but common side effects with cancer treatments can include tiredness, nausea, or changes in blood tests. The study team will explain potential specific side effects of these drugs.

How long would I be in the study?

The exact length of time you'd participate can vary. It depends on how you respond to the treatment and the overall study plan. The study team can give you more details.