AuthorisedTherapeutic confirmatory (Phase III)Interventional

OPTIMA YOUNG : Optimal Personalized Treatment of early breast cancer using Multi-parameter Analysis : focus on YOUNGer women

The OPTIMA YOUNG study is for women under menopause who have a specific type of early breast cancer (HR-positive/HER2-negative) that is considered high-risk, based on its size and whether it has spread to nearby lymph nodes. The study aims to find the best way to treat this cancer to prevent it from returning. Researchers are comparing various medicines like Letrozole, Tamoxifen, and chemotherapy drugs such as Docetaxel and Cyclophosphamide. They are also looking at hormone treatments like Anastrozole and Goserelin. The main goal is to see how many women remain free from breast cancer for a certain period. They also want to understand the quality of life for women on these treatments, including any side effects, and how certain tests might help decide the best treatment path.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Unicancer

Enrolment target

2,270

Start

23 Sep 2025

What is this study about?

The OPTIMA YOUNG study is a research project designed for younger women who have recently been diagnosed with a specific type of early breast cancer. This type is generally called 'HR-positive/HER2-negative'. Doctors consider this particular cancer to be 'high-risk' if it has reached a certain size or if it has spread to a few nearby lymph nodes.

The main purpose of this study is to discover the best treatment plan to prevent the cancer from coming back. Doctors want to understand which combinations of available breast cancer medications work most effectively for these women. The study will look closely at how long women stay free of breast cancer after their treatment. They also want to see if a special test, called a Prosigna® score, can help doctors decide who might benefit most from certain treatments like chemotherapy, and who might be able to avoid it.

Beyond simply looking at cancer returning, the study also aims to understand how these treatments affect a woman's daily life. This includes checking on their quality of life, any side effects they might experience, and their general well-being. Researchers will also look at important health aspects like bone health, heart health, and even fertility, as some treatments can have an impact on these. Ultimately, the goal is to personalise treatment more effectively for younger women with this kind of breast cancer.

Key takeaways

Targets younger women (premenopausal) with a specific type of early breast cancer.
Aims to find the most effective treatment to prevent cancer recurrence.
Compares various established hormone and chemotherapy drugs.
Investigates the impact of treatment on quality of life and long-term health.
Looks at how specific tests can help tailor treatment choices.
Participation is voluntary, and your care will be closely monitored.

Who may be eligible?

This study is looking for women who are still having their periods (premenopausal) and have been diagnosed with a specific type of early breast cancer. This breast cancer must be 'HR-positive' and 'HER2-negative'. It is considered high-risk based on certain features.

To be considered high-risk for this study, your cancer must meet one of these descriptions: either it has spread to 1 to 3 nearby lymph nodes (regardless of the tumour size), OR if it hasn't spread to any larger lymph nodes (even if there are very tiny cancer cells in them), the tumour itself must be 50mm (about 2 inches) or larger.

You must be at least 18 years old to take part in this study. There is no upper age limit, but as mentioned, you must be premenopausal, meaning you are still having monthly periods.

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 is still having monthly periods (premenopausal)?
Have you been diagnosed with breast cancer that is 'HR-positive' and 'HER2-negative'?
Does your cancer involve 1 to 3 lymph nodes, or is the main tumour 50mm or larger if nodes are clear?
Are you at least 18 years old?
Are you willing to consider different treatment approaches including hormone therapy and chemotherapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the OPTIMA YOUNG study, you will receive one of the treatment plans being investigated. These plans involve various medications, which can include hormone therapies like Letrozole, Anastrozole, Tamoxifen, Exemestane, Goserelin, Triptorelin, or Leuprorelin Acetate. Some plans might also include chemotherapy drugs such as Docetaxel, Paclitaxel, Epirubicin, Doxorubicin, and Cyclophosphamide. The specific treatment plan you receive will be decided by the study doctors.

Throughout the study, you will have regular visits with your medical team. These visits will involve check-ups, potentially blood tests, and discussions about how you are feeling and any side effects you might be experiencing. You will also be asked to complete questionnaires about your quality of life, emotional well-being, and other health aspects. The total duration of your participation, including follow-up appointments, will depend on your specific treatment plan and how long doctors need to monitor your health and recovery.

Potential risks and benefits

Taking part in a clinical trial like OPTIMA YOUNG could offer the potential benefit of receiving an active treatment that may be more effective for your type of breast cancer. You'll also be closely monitored by a dedicated medical team. However, with any medical treatment, there are potential risks, including side effects from the medications. Some specific risks mentioned in the study include potential effects on bone health (like fractures), heart health, and fertility. You will be given detailed information about all potential side effects before you decide to join. Remember, taking part in any study is entirely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (7)

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

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Unverified
Poland
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Unverified
France
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Unverified
Italy
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Unverified
Greece
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Unverified
Spain
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Unverified
Ireland
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Unverified
Belgium

Common questions

What kind of breast cancer is this study for?

This study is for women with early-stage, HR-positive/HER2-negative breast cancer that doctors consider 'high-risk' based on its size or spread to lymph nodes.

What does 'HR-positive/HER2-negative' mean?

This describes specific features of your cancer cells that help doctors understand how they might grow and which treatments might work best. It means the cancer is sensitive to hormones but not to a protein called HER2.

What treatments are being tested?

The study is comparing various existing medications including hormone therapies (like Letrozole, Tamoxifen) and chemotherapy drugs (like Docetaxel, Cyclophosphamide).

What is the main goal of the study?

The main goal is to find the best way to prevent the cancer from coming back and to understand how these treatments affect quality of life for younger women.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time without having to give a reason, and it will not affect your standard medical care.