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Study of Trifluridine and Tipiracil in Patients with ER-Positive, HER2-Negative Advanced Breast Cancer After Chemotherapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of breast cancer known as ER-positive, HER2-negative advanced breast cancer. This type of cancer is characterized by the presence of estrogen receptors (ER-positive) and the absence of a protein called HER2 (HER2-negative). The study is investigating the effects of a medication called trifluridine/tipiracil, which is available in tablet form under the brand name Lonsurf. This medication is being tested in patients who have previously received chemotherapy treatments, including drugs like taxane and capecitabine.

The purpose of the study is to evaluate how effective trifluridine/tipiracil is in keeping the cancer from progressing over a period of eight weeks. Participants in the study will take the medication orally, and their health will be monitored to see if the cancer remains stable. The study will also look at other factors such as the overall survival without cancer progression, the response rate of the cancer to the treatment, any side effects experienced, and the quality of life of the participants.

This trial is part of ongoing research to find better treatment options for patients with advanced breast cancer who have limited options after previous chemotherapy. The study aims to provide valuable information on the potential benefits and risks of using trifluridine/tipiracil in this specific group of patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of advanced breast cancer, and previous treatments.
The study involves patients with ER-positive, HER2-negative advanced breast cancer who have previously received chemotherapy.
Step 2
Medication administration
The medication used in this study is Lonsurf, which contains the active substances trifluridine and tipiracil hydrochloride.
Lonsurf is administered in the form of film-coated tablets, available in two dosages: 20 mg/8.19 mg and 15 mg/6.14 mg.
The medication is taken orally, following the prescribed dosage and schedule provided by the healthcare team.
Step 3
Treatment duration
The primary objective is to evaluate the effectiveness of the medication over an 8-week period.
The study aims to determine the percentage of patients who remain progression-free during this time.
Step 4
Monitoring and assessments
Regular assessments are conducted to monitor the patient's health and response to the treatment.
These assessments include imaging tests to evaluate disease progression and other health checks as necessary.
Step 5
End of study
The study is estimated to conclude by December 31, 2025.
Upon completion, the results will be analyzed to assess the primary and secondary endpoints, including progression-free survival, response rate, adverse events, and quality of life.

Who can join the trial?

16 criteria

Adult women who are 18 years or older.
Have a confirmed diagnosis of **metastatic** (cancer that has spread to other parts of the body) or **locally advanced breast cancer** (cancer that has spread to nearby tissues but not distant parts of the body) that cannot be cured with surgery or radiation.
Have breast cancer that is **ER positive** (estrogen receptor positive) and/or **PR positive** (progesterone receptor positive) and **HER2 negative** (a type of protein not present in the cancer cells).
Have cancer that is getting worse based on imaging tests.
Have been treated with **capecitabine** (a type of chemotherapy) for metastatic breast cancer and no more than two other chemotherapy treatments, including a **taxane** (a type of chemotherapy drug).
Have cancer that can be measured according to specific guidelines (RECIST v.1.1). Tumors that were treated with radiation or other local treatments can only be measured if they have clearly gotten worse after treatment.
Have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
Have a life expectancy of at least 12 weeks.
Have adequate function of organs, bone marrow, and blood clotting, shown by specific blood test results:
**Absolute neutrophil count (ANC)** of at least 1.5 x 10⁹/L (a measure of a type of white blood cell).
**Platelets** of at least 75 x 10⁹/L (a measure of cells that help with blood clotting).
**Hemoglobin (Hgb)** of at least 5.6 mmol/L (a measure of red blood cells).
**Serum aspartate aminotransferase (AST)** and **alanine aminotransferase (ALT)** levels no more than 2.5 times the upper limit of normal (or no more than 5 times if there are liver metastases).
**Total serum bilirubin** no more than 1.5 times the upper limit of normal (or no more than 3 times for patients with Gilbert Syndrome).
**Creatinine clearance** of at least 60 ml/min (a measure of kidney function).
Have recovered from any severe side effects of previous cancer treatments or surgeries to a mild level, except for hair loss or other side effects that are not considered a safety risk.

Who cannot join the trial?

7 criteria

Patients who have not been diagnosed with advanced breast cancer cannot participate. Advanced breast cancer means the cancer has spread beyond the breast to other parts of the body.
Only patients who are female can participate. Male patients are not eligible.
Patients who have not been previously treated with 2 or 3 lines of chemotherapy are excluded. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells.
Patients who have not received treatment with taxane are excluded. Taxane is a type of chemotherapy drug used to treat breast cancer.
Patients who have not been treated for metastatic breast cancer with capecitabine are excluded. Metastatic breast cancer is when cancer has spread to other parts of the body, and capecitabine is a drug used to treat it.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study but is not specified here.
Patients who are part of a vulnerable population are excluded. Vulnerable populations may include groups like children or those unable to give consent.

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Frisius
Heerenveen, The Netherlands

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Investigated drugs

Trifluridine/Tipiracil is a medication used in this study to treat patients with advanced breast cancer that is ER-positive and HER2-negative. These patients have already received chemotherapy treatments, including taxane and capecitabine, for their metastatic breast cancer. The goal of using trifluridine/tipiracil in this trial is to see how effective it is in keeping the cancer from progressing over an 8-week period.

What is already known about the treatment

Trifluridine/Tipiracil – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating advanced breast cancer, specifically in patients with ER-positive, HER2-negative types who have previously undergone chemotherapy. The main therapeutic indication is to help manage advanced breast cancer by slowing disease progression. At the molecular level, trifluridine works by incorporating into DNA, disrupting its function, while tipiracil prevents the breakdown of trifluridine, enhancing its effectiveness. It is classified pharmacologically as an antineoplastic agent.

Investigated diseases

Advanced Breast Cancer – This is a stage of breast cancer where the disease has spread beyond the initial site to other parts of the body. It often involves the lymph nodes, bones, liver, lungs, or brain. The progression of advanced breast cancer can vary, with some patients experiencing rapid spread while others may have a slower progression. Symptoms can include persistent pain, fatigue, and changes in the breast or surrounding areas. The disease is typically characterized by its resistance to initial treatments, requiring more advanced therapeutic approaches. It is often classified based on hormone receptor status, such as ER-positive or HER2-negative, which can influence the course of the disease.