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Study on Darolutamide and Capecitabine for Patients with Advanced Triple-Negative Androgen Receptor Positive Breast Cancer

Verified siteRegistered drugNo placebo

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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 triple-negative androgen receptor positive breast cancer. This specific form of cancer is characterized by the absence of three common receptors that are often found in breast cancer, making it more challenging to treat. The study is investigating the effectiveness of two treatments: darolutamide and capecitabine. Darolutamide, also known by its code names ODM-201 and BAY 1841788, is a medication that targets androgen receptors, which are proteins that can influence the growth of cancer cells. Capecitabine is a chemotherapy drug that is used to stop the growth of cancer cells by interfering with their DNA.

The purpose of this study is to evaluate how well these treatments work in patients with this type of breast cancer. Participants in the study will be randomly assigned to receive either darolutamide or capecitabine. The study will monitor the participants over a period of time to see how their cancer responds to the treatment. This includes checking if the cancer shrinks, remains stable, or progresses. The study will also look at the safety of the treatments by observing any side effects that may occur.

Throughout the study, participants will have regular check-ups to assess their health and the status of their cancer. The study aims to provide valuable information on the effectiveness of these treatments, which could help improve future care for patients with triple-negative androgen receptor positive breast cancer. The study is expected to continue until the end of 2025, with results being analyzed to determine the potential benefits of darolutamide and capecitabine for this challenging form of breast cancer.

The research process

The trial runs in 6 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, health status, and type of breast cancer.
A written informed consent form must be signed before any study-specific procedures begin.
Step 2
Treatment assignment
Participants are randomly assigned to one of two treatment groups: one receiving darolutamide and the other receiving capecitabine.
Both medications are administered orally in the form of film-coated tablets.
Step 3
Medication administration
For the darolutamide group, the dosage is 300 mg per tablet. The specific frequency and duration of administration are determined by the study protocol.
For the capecitabine group, the dosage and administration schedule are also defined by the study protocol.
Step 4
Monitoring and evaluation
Participants undergo regular monitoring to assess the effectiveness of the treatment and any side effects.
The primary goal is to evaluate the antitumor activity at 16 weeks, measuring the clinical benefit rate, which includes complete response, partial response, or stable disease.
Step 5
Follow-up assessments
Secondary assessments include evaluating the clinical benefit rate at 24 weeks, objective response rate, duration of overall response, overall survival, and progression-free survival.
Safety evaluations are conducted to monitor the type, frequency, and severity of any adverse reactions.
Step 6
Completion of study
The study is estimated to conclude by December 31, 2025.
Participants may continue to be monitored for long-term outcomes such as overall survival and progression-free survival.

Who can join the trial?

18 criteria

Must be a woman who is 18 years old or older.
Must have normal liver function, which means certain liver tests should be within specific limits. If you have a condition called Gilbert's disease, some exceptions apply.
Must have a creatinine clearance of at least 50 mL/min. This is a measure of how well your kidneys are working.
Uracilemia, a specific blood test, must be less than 16 ng/ml.
Blood pressure must be below 160/95 mm Hg. If you have high blood pressure, it should be controlled with treatment.
Heart function must be normal, with a cardiac ejection fraction of 50% or more. This is checked with a heart scan.
If you are premenopausal, you must agree to use effective birth control during the study and for at least 6 months after finishing the study treatment.
Must be able to follow the study rules and procedures.
Must sign a written consent form before any study-related procedures begin.
Must have health insurance.
Must have breast cancer that has come back or spread and cannot be removed by surgery.
Must have **triple-negative breast cancer**, which means the cancer does not have certain receptors that are common in other breast cancers.
Must have **androgen receptor (AR)-positive** cancer, meaning at least 10% of the cancer cells have these receptors.
If the cancer has come back, you should not have had more than one type of chemotherapy for advanced cancer, unless the cancer is life-threatening. You may have had other treatments before.
If you are premenopausal, it is recommended to use a treatment that affects hormone levels, as androgens might work differently in premenopausal women.
Must have cancer that can be measured or evaluated according to specific guidelines.
Must have an **ECOG** performance status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
Must have normal blood function, with specific levels of white blood cells, platelets, and hemoglobin.

Who cannot join the trial?

5 criteria

Patients who do not have **triple-negative androgen receptor positive** breast cancer. This means the cancer does not have certain proteins that are usually found in breast cancer.
Patients whose cancer is not **locally recurrent** or **metastatic**. Locally recurrent means the cancer has come back in the same area, and metastatic means it has spread to other parts of the body.
Patients who are not female, as the study is only for female participants.
Patients who are not in the specified age range for the study.
Patients who are part of a vulnerable population that the study does not include.

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Institut Regional Du Cancer De Montpellier
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Montpellier, France

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Investigated drugs

Darolutamide
is a medication used in this trial to treat patients with a specific type of breast cancer known as triple-negative, androgen receptor positive breast cancer. It works by blocking the effects of androgens, which are hormones that can promote the growth of cancer cells. The goal of using darolutamide in this study is to see if it can help slow down or stop the growth of the cancer.
Capecitabine
is another medication being tested in this trial for the same type of breast cancer. It is a type of chemotherapy that works by interfering with the DNA of cancer cells, preventing them from growing and dividing. The study aims to determine if capecitabine can effectively control the cancer and improve the patient's condition.

What is already known about the treatment

Darolutamide
This medication is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating certain types of breast cancer, specifically triple-negative, androgen receptor-positive, locally recurrent or metastatic breast cancer. Darolutamide works by blocking androgen receptors, which can slow down or stop the growth of cancer cells that rely on these hormones. It is classified as an androgen receptor inhibitor.
Capecitabine
This medication is taken orally as a tablet. It is being evaluated in clinical trials for its potential to treat triple-negative, androgen receptor-positive, locally recurrent or metastatic breast cancer. Capecitabine is a chemotherapy drug that works by interfering with the DNA synthesis of cancer cells, ultimately leading to their death. It belongs to the class of antimetabolites.

Investigated diseases

Triple-negative breast cancer – This is a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER2 protein. It is characterized by the absence of these receptors, making it more challenging to treat with hormone therapy or drugs that target HER2. This subtype can be more aggressive and is more likely to spread and recur compared to other breast cancer types. The specific subtype mentioned, androgen receptor positive, suggests that the cancer cells may still respond to treatments targeting the androgen receptor. It can present as locally recurrent, meaning it has returned in the same area, or as metastatic, indicating it has spread to other parts of the body. The progression of this disease can vary, but it often requires a combination of treatments due to its complex nature.