AuthorisedTherapeutic exploratory (Phase II)Interventional

A multicenter, multicohort, phase 2 platform trial to personalize second-line treatment intensity and targeting in HR-positive, HER2-negative metastatic breast cancer through an integrated liquid biopsy algorithm.

This study is designed for women who have advanced breast cancer that is hormone receptor-positive and HER2-negative, meaning it has spread to other parts of the body. The main goal is to find the most effective second treatment for these patients. Researchers will use a 'liquid biopsy,' which is a blood test, to look for specific changes in the cancer cells. This information will help doctors choose the best treatment for each individual. Different medications will be tested to see which ones are most successful at shrinking the cancer or keeping it stable for at least six months. The study also looks at how long people live and how long their cancer stays under control. It's an important step towards making breast cancer treatment more personal and effective.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centro Di Riferimento Oncologico Di Aviano

Enrolment target

159

Start

31 Mar 2026

Metastatic breast cancer

What is this study about?

This study is looking into new ways to treat breast cancer that has spread to other parts of the body. This type of cancer is called 'metastatic breast cancer.' Specifically, it's for breast cancer that responds to hormones (HR-positive) but doesn't have too much of a protein called HER2 (HER2-negative). If your initial treatment hasn't worked as well as hoped, this study is exploring the best next steps.

The main idea behind this research is to make treatment more personal. Instead of a one-size-fits-all approach, doctors want to understand the unique features of each person's cancer. They'll do this using a special blood test called a 'liquid biopsy.' This test helps identify specific changes in cancer cells that can guide treatment decisions. By understanding these changes, doctors can choose medicines that are more likely to target a patient's specific cancer, hopefully leading to better results.

Throughout the study, researchers will be carefully observing how well different treatments work. They're particularly interested in seeing if the treatments can shrink the cancer, or at least stop it from growing, for six months or longer. They will also look at how long people live and how well they feel. The goal is to discover which treatments are most effective and to use the information from the liquid biopsy to help decide which treatment is best for each individual woman.

Key takeaways

This study is for women with advanced, hormone-positive, HER2-negative breast cancer.
It aims to find the most effective second treatment by personalising it to your cancer.
A special blood test (liquid biopsy) will help guide which treatment you receive.
You might receive one of several different medications, given as injections, pills, or infusions.
The study will track how well the treatments shrink or stop the cancer and how you feel.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

This study is specifically for women aged 18 and over who have been diagnosed with metastatic breast cancer. This means the breast cancer has spread from the breast to other parts of the body.

To be considered for this study, your breast cancer must be 'hormone receptor-positive' (often shortened to HR-positive) and 'HER2-negative'. This is a way doctors classify breast cancer based on certain characteristics of the cancer cells. Your doctors will be able to tell you if your cancer fits these categories.

If you meet these general criteria, your doctor will be able to discuss if this study is suitable for your individual situation, taking into account your overall health and any previous treatments.

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 aged 18 or older?
Do you have breast cancer that has spread to other parts of your body?
Has your doctor told you your breast cancer is 'hormone receptor-positive'?
Has your doctor told you your breast cancer is 'HER2-negative'?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given one of several possible medications. Your doctors will choose the medication they think is best for you based on special blood tests that look for changes in your cancer cells. These medications come in different forms, including injections, tablets, or infusions (given through a drip).

You will have regular visits to the hospital or clinic to receive your assigned treatment and for check-ups. During these visits, doctors will monitor your health, check for any side effects, and assess how well the treatment is working. This will likely involve blood tests, scans, and physical examinations. You'll continue with the treatment and follow-up for as long as it is benefiting you and you are tolerating it well. The total duration of your participation will depend on how you respond to the treatment, but follow-up will typically continue for a period after your main treatment has ended.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a novel or personalised treatment approach that could be more effective for your specific cancer. You'll be closely monitored by a dedicated medical team. However, like all medications, the treatments in this study can have side effects, which vary from person to person. These will be fully explained before you agree to take part. There is also no guarantee that the treatment will work for you. You are free to withdraw from the study at any time, for any reason, without affecting your standard 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
Italy

Common questions

What is 'metastatic breast cancer'?

This means your breast cancer has spread from where it started to other parts of your body. Doctors also call it advanced breast cancer.

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

These are specific features of your cancer cells. HR-positive means the cancer responds to hormones, and HER2-negative means it doesn't have too much of a protein called HER2. Your doctor can confirm if your cancer has these features.

What is a 'liquid biopsy'?

It's a simple blood test that helps doctors find tiny pieces of cancer cells or DNA in your blood. This can give them clues about how best to treat your cancer.

What are the main goals of this study?

The study aims to find the best second treatment for your type of breast cancer, using information from a blood test, and to see if these treatments can keep the cancer under control for a long time.

Will I definitely get one of the new drugs?

If you join the study, your doctor will decide which treatment is best for you, based on the results of the special blood tests. You will receive one of the study treatments.