AuthorisedTherapeutic exploratory (Phase II)Interventional

NoELA_No Endocrine therapy in small HR+ HER2- low relapse risk Luminal A early breast cancer, a single-arm de-escalation trial

This study, called NoELA, is for postmenopausal women who have been diagnosed with a very early and low-risk type of breast cancer. Doctors describe this specific type as 'hormone receptor positive, HER2 negative, Luminal A' and where the tumour is small. The main goal is to find out if these women can safely avoid taking hormone therapy after their initial treatment. Researchers will carefully track if the cancer returns and will also look at any side effects and how participants' quality of life is affected. This could help personalise treatments in the future, meaning some women might avoid unnecessary medication and its side effects.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Unicancer

Enrolment target

630

Start

21 Apr 2026

Postmenopausal patients with small (pT1a-b pN0) hormone receptor positive (HR⁺) and HER2 negative (HER2⁻) early breast cancer with a Luminal A phenotype and at low risk of recurrence.

What is this study about?

Imagine you've been diagnosed with early breast cancer. For many women, hormone therapy is a standard treatment to help stop the cancer from coming back. This study, called NoELA, wants to explore a new idea: could some women with a very specific, low-risk type of early breast cancer actually do well without hormone therapy? The study focuses on postmenopausal women whose cancer cells respond to hormones (called 'hormone receptor positive'), but don't have too much of a protein called HER2 ('HER2 negative'), and are classified as 'Luminal A' with a small tumour.

The main aim is to see how long women in this group stay healthy without their cancer returning. This period is called the 'relapse-free interval'. The researchers will track whether the cancer comes back in the same breast, in nearby areas, or spreads to other parts of the body. They will also look at other important aspects like how long women live, and whether any new cancers develop, either in the treated breast or the other breast.

Ultimately, this research could lead to more personalised treatment plans. If the study shows that certain women can safely skip hormone therapy, it could mean avoiding uncomfortable side effects and improving their quality of life. This is a vital step in tailoring cancer treatment so that each person gets exactly what they need, and nothing more.

Key takeaways

This study is for postmenopausal women with a specific, very early, low-risk breast cancer.
It explores if some women can safely skip hormone therapy.
The aim is to prevent cancer recurrence and improve quality of life by avoiding side effects.
Participation involves careful monitoring over several years.
This research could lead to more personalised breast cancer treatments.
It does not involve new medication, but rather *not* taking a standard one.

Who may be eligible?

This study is specifically looking for postmenopausal women. This means you must have already gone through menopause, which is when your periods have permanently stopped.

You should have been diagnosed with a very early stage of breast cancer. Specifically, your tumour needs to be small (doctors call this pT1a-b pN0). Your cancer cells must also be ‘hormone receptor positive’ (meaning they grow in response to hormones) and ‘HER2 negative’ (meaning they don't have too much of a certain protein called HER2). It also needs to be of a type called 'Luminal A', which usually means it's less aggressive and has a lower chance of coming back.

The study is designed for women who are considered to have a low risk of their cancer returning. Your doctor can help determine if your specific breast cancer fits all these detailed criteria.

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 postmenopausal woman?
Was your breast cancer diagnosed as small (pT1a-b pN0)?
Is your breast cancer classified as 'hormone receptor positive'?
Is your breast cancer classified as 'HER2 negative'?
Is your breast cancer considered 'Luminal A'?
Has your doctor confirmed you are at low risk of your cancer returning?

Answer every question to see your result.

What does participation involve?

If you join this study, you will not receive hormone therapy. Instead, doctors will carefully monitor your health over several years. This will involve regular check-ups, scans, and blood tests to make sure the cancer hasn't returned and to monitor your general health. You will also be asked to complete questionnaires about your quality of life, which help researchers understand your well-being and any symptoms you might experience. The first part of the study will involve active monitoring for at least 5 years, and researchers will continue to collect information for up to 10 years to understand long-term effects.

Potential risks and benefits

A potential benefit of taking part is that you might avoid the side effects associated with hormone therapy. If this study successfully shows that some women don't need hormone therapy, it could change future treatment for similar cases. However, there is a risk that by not taking hormone therapy, your cancer could be more likely to return. The study will carefully monitor participants for any signs of recurrence. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
France

Common questions

What is 'postmenopausal'?

This means you have permanently stopped having your monthly periods, usually for at least 12 consecutive months without any other cause.

What does 'hormone receptor positive' mean?

It means the cancer cells use hormones like oestrogen to grow. Hormone therapy usually works by blocking this process.

What does 'HER2 negative' mean?

It means the cancer cells don't make too much of a protein called HER2. This is important because HER2 positive cancers are treated differently.

What does 'low relapse risk' mean?

It means doctors believe, based on specific features of your cancer, that it has a relatively low chance of returning after initial treatment.

Will I still get other breast cancer treatments?

Yes, this study is about whether hormone therapy is needed, not other standard treatments like surgery, chemotherapy, or radiotherapy, which you would have received as per your doctor's advice.