Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase 1 /2 study for the safety, efficacy, pharmacokinetic and pharmacodynamics evaluation of amcenestrant (SAR439859 ), administered orally as monotherapy, then in combination with other anti-cancer therapies in postmenopausal women with estrogen receptor-positive advanced breast cancer

This research study is for postmenopausal women who have advanced breast cancer that is sensitive to hormones (oestrogen receptor-positive). We are looking at a new medicine called amcenestrant. The study aims to find out how safe amcenestrant is and how well it works. We will test it as a single treatment and also in combination with other anti-cancer drugs like IBRANCE and Verzenios. This is an early-stage study (Phase 1 and 2), meaning it's one of the first times this drug is being given to people. We will also monitor how the body handles the drug and its effects on the cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

Start

23 Oct 2024

Cancer

What is this study about?

This study is investigating a new treatment called amcenestrant for postmenopausal women with advanced breast cancer that is considered 'oestrogen receptor-positive'. This type of breast cancer often uses oestrogen to grow. The overarching goal of this study is to understand more about amcenestrant – how it behaves in the body, its safety profile, and how effectively it can shrink or control cancer growth.

This is an early-stage clinical trial, combining Phase 1 and Phase 2. Phase 1 trials are usually among the first times a new drug is given to humans, focusing primarily on safety, identifying the best dose, and understanding how the body processes the drug. Phase 2 trials then build on this by looking more closely at how well the drug works against the cancer, while still monitoring safety. Researchers will first test amcenestrant on its own, and then explore its effects when combined with existing, approved anti-cancer medications such as IBRANCE (palbociclib) and Verzenios (abemaciclib).

The information gathered from this study is crucial for determining if amcenestrant could be a promising new option for women with this type of breast cancer. By studying the drug both alone and in combination with other treatments, researchers hope to find the most effective and safest ways to use it. This careful, step-by-step approach is standard in medical research to ensure new treatments are thoroughly tested before they become widely available.

Key takeaways

This study is testing a new drug for advanced breast cancer.
It's for postmenopausal women with oestrogen receptor-positive breast cancer.
The drug (amcenestrant) is being tested alone and with other cancer medicines.
It's an early-stage study, focusing on safety and how well it works.
Participation involves regular clinic visits for monitoring and tests.

Who may be eligible?

This study is seeking women who have already gone through menopause. All participants must be at least 18 years old.

The specific type of breast cancer being studied is advanced breast cancer that is 'oestrogen receptor-positive'. This means your cancer's growth is often linked to the hormone oestrogen.

There may be other health requirements or previous treatments that would affect whether you can join the study. Your doctor would help determine if this study is a good fit for you.

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 a woman who has gone through menopause?
Are you 18 years old or older?
Do you have advanced breast cancer?
Has your breast cancer been identified as 'oestrogen receptor-positive'?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given the new drug, amcenestrant. Depending on the stage of the study, you might receive amcenestrant on its own, or combined with other approved cancer medications like IBRANCE or Verzenios. These are taken by mouth as tablets or capsules.

You will have regular visits to the hospital or clinic. During these visits, the study team will carry out various tests, which may include blood tests, scans (like PET scans to see how the cancer is responding), and physical examinations. This is to closely monitor your health, check for any side effects, and see how the medication is affecting your cancer. The total length of time you'll be involved in the study, including follow-up, will be discussed with you by the research team.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, and closely monitored care from a dedicated medical team. However, there are also potential risks, including side effects from the study drugs that are not yet fully known, and the possibility that the treatment may not work for you. 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
Belgium
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Unverified
Spain

Common questions

What does 'postmenopausal' mean?

It means you have naturally stopped having your monthly periods for at least 12 consecutive months, or have had surgery that stopped them.

What is 'oestrogen receptor-positive breast cancer'?

This type of breast cancer has cells with special proteins (receptors) that attach to oestrogen, which can help the cancer grow. Treatments often aim to block this.

What are IBRANCE and Verzenios?

These are existing, approved medicines used to treat certain types of advanced breast cancer, often alongside hormone therapy.

Will I know if I'm getting the new drug or a combination?

Yes, this study is not a 'blinded' study where you wouldn't know. The doctors will tell you which treatment plan you are on.

Are there any costs involved for me?

Generally, clinical trial medications and study-related tests are covered by the trial sponsor. Any travel costs or other expenses would be discussed by the study team.