Personalizing treatment for patients with HR-positive, HER2-negative metastatic breast cancer using fulvestrant, elacestrant, capivasertib, capecitabine, or a drug combination.

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What is this study about?

This study is focused on Metastatic Breast Cancer, which is a type of cancer that has spread from the original breast location to other parts of the body. Specifically, the research looks at a subtype known as HR-positive, HER2-negative cancer. This means the cancer cells have receptors that respond to certain hormones, but they do not have high levels of a specific protein that helps cancer grow. The purpose of the study is to evaluate a new method for choosing the best second-line treatment, which is the next medication used after the first treatment has stopped working. This method uses a liquid biopsy, a way to look for signs of cancer by testing a sample of blood.

Several different medications may be used during the study depending on the results of the blood tests. These include fulvestrant, trastuzumab deruxtecan, capecitabine, capivasertib, and elacestrant. Some of these medications are taken as tablets, while others are given as an intravenous infusion, which is medicine delivered directly into a vein, or as an intramuscular injection, which is medicine injected into a muscle.

During the study, blood samples will be analyzed to find somatic alterations, which are changes in the DNA of the cancer cells. The study will also monitor CTCs, or circulating tumor cells, which are cancer cells that have broken away from a tumor and are traveling through the bloodstream. Participants will receive different treatments based on these findings to see which approach works best for their specific type of cancer.

Who Can Join the Study?

Female patients, including those who have gone through menopause (the period when menstrual cycles stop) and those who have not.
A confirmed diagnosis of adenocarcinoma, which is a type of cancer that starts in the gland cells of the breast.
Evidence that the cancer has metastasized, meaning it has spread from the original breast site to other parts of the body.
Women who are able to become pregnant must have a negative pregnancy test using highly sensitive blood or urine tests within 7 days before being assigned to a study group.
Women who are currently breastfeeding must stop nursing during the time they are receiving the study treatment.
The ability and willingness to follow all scheduled appointments, treatment plans, laboratory tests (medical tests that analyze samples like blood), and other study requirements.
Providing written informed consent, which is a signed document stating that you understand the study and agree to participate.
The cancer must be Estrogen Receptor (ER) positive and/or Progesterone Receptor (PgR) positive. This means the cancer cells have specific proteins that allow them to grow when triggered by hormones. This must be confirmed through immunohistochemistry (IHC), a laboratory method used to detect specific proteins in tissue samples.
The cancer must be HER2 negative, meaning the cancer does not have high levels of a specific protein that promotes cancer growth. This is confirmed using special tests called FISH or IHC.
You must be at least 18 years old when signing the consent form.
The cancer must have progressed, or gotten worse, after receiving at least 6 months of first-line endocrine therapy (hormone treatment) combined with CDK 4/6 inhibitors (a type of drug used to stop cancer cells from dividing).
The disease must be evaluable, meaning the cancer can be measured or assessed using standard medical rules called RECIST 1.1 to see if the treatment is working.
An ECOG performance status of 0 or 1, which is a scale used by doctors to measure how well a patient can perform daily activities and their overall physical health.
Having adequate organ function, meaning the kidneys, liver, and bone marrow (the tissue inside bones that produces blood cells) are working correctly.
Women of childbearing potential must agree to avoid pregnancy by either refraining from sexual intercourse or using highly effective contraceptive methods (birth control) during treatment and for at least 6 months after the last dose.

Who Cannot Join the Study?

Being a male.
Being pregnant.
Having a diagnosis of any other type of cancer within the last 3 years, unless it was a specific, well-treated skin cancer or a very early stage of cervical cancer.
Having a known allergic reaction to any of the medicines or substances used in this study.
Having a history or current diagnosis of HER2-positive or triple-negative breast cancer, which are specific types of breast cancer defined by certain proteins on the cancer cells.
Having already received chemotherapy (medicine used to kill cancer cells) for cancer that has spread to other parts of the body.
Having the cancer get worse before completing 6 months of first-line endocrine therapy (hormone therapy used as the initial treatment) combined with CDK 4/6 inhibitors (a specific type of hormone therapy medicine).
Having undergone major surgery less than 28 days before being assigned to a study group.
Having any ongoing moderate to severe side effects (defined as Grade 2 or higher) from previous treatments or surgeries, such as hair loss or nerve tingling, unless the doctor decides these are not a safety risk.
Having an active, uncontrolled infection that is severe, including infections like Hepatitis B, Hepatitis C, or HIV.
Having any other uncontrolled illness, such as mental health conditions, that the doctor believes would make it difficult to follow the study rules, increase the risk of adverse events (unexpected medical problems), or make it hard to give official permission to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Humanitas Istituto Clinico Catanese S.p.A.	Misterbianco	Italy
Ofrdagyc Sem Bqabkzf dr Veewxgx	Vicenza	Italy
Iiwasqum Rqsbbvmiy Plm Lm Sxzlud Dmc Tjkyyg Dsxz Amxyvzu Iknk Slivbh	Meldola	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.06.2026

Trial locations

Investigated drugs:

Fulvestrant is a medication given as an injection into the muscle. It works by blocking the effects of estrogen, a hormone that can help certain types of breast cancer grow.

Trastuzumab deruxtecan is a treatment given through an intravenous infusion, which means it is delivered directly into the bloodstream. It is a type of targeted therapy designed to attack specific proteins on cancer cells.

Capecitabine is a medication taken orally in the form of tablets. It is a chemotherapy drug used to stop the growth of cancer cells.

Capivasertib is a medication taken orally in the form of tablets. It is used to interfere with specific signaling pathways that cancer cells use to grow and survive.

Elacestrant is a medication taken orally in the form of tablets. It is a type of hormone therapy that works by blocking estrogen receptors in cancer cells to prevent them from growing.

Metastatic breast cancer – This is a type of cancer where breast cancer cells have spread from the original site in the breast to other parts of the body. The cells can travel through the bloodstream or the lymphatic system to reach distant organs. As the disease progresses, the cancer cells grow and multiply in these new locations. This process can involve various organs such as the bones, lungs, liver, or brain. The condition is often characterized by the specific biological features of the cells, such as hormone receptor status.

Trial ID:

2025-523460-21-00

Protocol code:

interACT

Trial Phase:

Therapeutic exploratory (Phase II)

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Personalizing treatment for patients with HR-positive, HER2-negative metastatic breast cancer using fulvestrant, elacestrant, capivasertib, capecitabine, or a drug combination.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?