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Study of Bicalutamide and Abemaciclib for Patients with Advanced Androgen Receptor Positive Triple-Negative Breast Cancer

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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 androgen receptor positive triple-negative breast cancer (AR+ TNBC). This is a form of breast cancer that does not have the usual hormone receptors or the HER2 protein, but it does have receptors for androgens, which are male hormones. The study is investigating the effects of two medications: bicalutamide and abemaciclib. Bicalutamide is an antiandrogen, which means it blocks the effects of androgens, while abemaciclib is a CDK 4/6 inhibitor, a type of drug that helps stop cancer cells from growing.

The purpose of this study is to evaluate how effective the combination of bicalutamide and abemaciclib is in controlling the disease. Participants in the study will take these medications orally, in the form of film-coated tablets. The study will follow participants over a period of time to see how their cancer responds to the treatment. The main goal is to see if the cancer remains stable, shrinks, or disappears after 16 weeks of treatment.

Participants will be monitored throughout the study to assess the safety and any side effects of the treatment. The study will also look at how long the response to the treatment lasts and how it affects overall survival. This research aims to provide more information about the potential benefits of using bicalutamide and abemaciclib together for treating AR+ TNBC.

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, the patient must provide signed and dated written consent. This consent is necessary before any study-specific procedures, sampling, or analysis can begin.
For women of child-bearing potential, a negative pregnancy test is required within 7 days before starting treatment. Effective contraception must be used during the study and for 3 weeks after completing therapy.
Step 2
Initial assessment
The patient undergoes an initial assessment to confirm eligibility. This includes a biopsy-confirmed diagnosis of recurrent, unresectable, locally advanced, or metastatic androgen receptor positive triple-negative breast cancer (AR+ TNBC).
The patient must have measurable disease or evaluable bone-only disease that is progressive, as shown on pre-treatment imaging.
Step 3
Treatment initiation
The treatment involves taking two medications: bicalutamide and abemaciclib. Both are administered orally in the form of film-coated tablets.
The specific dosage and frequency of administration are determined by the study protocol and the patient's condition.
Step 4
Treatment duration
The primary objective is to evaluate the effectiveness of the treatment at 16 weeks. The disease control rate (DCR) is assessed at this time.
The treatment continues as per the study protocol, with regular monitoring and assessments to track the patient's response and any side effects.
Step 5
Monitoring and follow-up
Throughout the study, the patient is monitored for any adverse events or laboratory abnormalities. These are assessed for type, incidence, and severity.
Secondary outcomes, such as overall response rate, duration of response, progression-free survival, and overall survival, are also evaluated.
Step 6
Completion of study
The study is estimated to end by December 2027. Upon completion, the patient may undergo final assessments to evaluate the overall impact of the treatment.
The patient is advised to continue using effective contraception for 3 weeks following the completion of therapy.

Who can join the trial?

10 criteria

The patient must provide signed and dated written consent before any study-specific procedures, sampling, and analysis.
If the patient is a woman who can have children, she must have a negative pregnancy test within 7 days before starting treatment. She must also agree to use a highly effective method of birth control before joining the study, during the study, and for 3 weeks after completing therapy.
The patient must be a woman aged at least 18 years.
The patient must have a confirmed diagnosis of breast cancer that is recurrent, cannot be surgically removed, locally advanced, or has spread to other parts of the body. The cancer must be positive for the androgen receptor (AR), which means at least 1% of cancer cells show this receptor in tests.
The patient must have had breast cancer that was positive for estrogen receptor (ER) and/or progesterone receptor (PR) in more than 10% of cells in the past, but the latest test shows 10% or fewer cells with these receptors.
The patient must have measurable disease according to specific criteria or bone disease that is getting worse, as shown in imaging tests done before treatment.
The patient must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale, which means she can carry out daily activities with no significant deterioration in the last 2 weeks and has a minimum life expectancy of 12 weeks.
The patient must have had at least one prior treatment with a cytostatic regimen, which is a type of cancer treatment, in an advanced setting. There is no limit to the number of previous treatments. If the patient has 1-10% of cells with positive ER in the last test, she must have had at least one line of hormone therapy in an advanced setting.
The patient must have recovered from the immediate effects of previous cancer treatments, except for mild hair loss, anemia, or nerve damage. A waiting period of at least 21 days is required between the last chemotherapy dose and the first dose of the study drug, unless the patient received radiotherapy.
If the patient received radiotherapy, she must have completed it and fully recovered from its immediate effects. A waiting period of at least 14 days is required between the end of radiotherapy and joining the study.

Who cannot join the trial?

5 criteria

Patients who have not been diagnosed with locally advanced unresectable or metastatic androgen receptor positive triple negative breast cancer. This means the cancer cannot be removed by surgery and has spread to other parts of the body.
Patients who have not received at least one prior cytostatic regimen in an advanced setting. Cytostatic regimens are treatments that stop cancer cells from growing and dividing.
If the patient has ER low HER2 negative breast cancer, they must have received at least one line of endocrine therapy in an advanced setting. Endocrine therapy is a treatment that blocks or removes hormones that fuel certain cancers.
Patients who are not female, as the study is only for female subjects.
Patients who are part of a vulnerable population. This refers to groups of people who may need special protection or care, such as children or those with certain disabilities.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Gasthuiszusters Antwerpen
Verified
Antwerp, Belgium
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

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Investigated drugs

Bicalutamide
is a medication used in this trial as an antiandrogen. It works by blocking the effects of androgens, which are male hormones that can promote the growth of certain types of cancer cells. In this study, it is being used to help control the growth of androgen receptor-positive triple-negative breast cancer.
Abemaciclib
is an oral medication that acts as a CDK 4/6 inhibitor. It helps to slow down or stop the growth of cancer cells by interfering with specific proteins that are involved in cell division. In this trial, abemaciclib is used in combination with bicalutamide to treat patients with androgen receptor-positive triple-negative breast cancer.

What is already known about the treatment

Bicalutamide
Bicalutamide is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating certain types of breast cancer. It is primarily used for androgen receptor-positive triple-negative breast cancer that has progressed after previous treatments. Bicalutamide works by blocking the action of male hormones, which can promote cancer growth. It is classified as an antiandrogen medication.
Abemaciclib
Abemaciclib is taken orally as a tablet and is under investigation in clinical trials for its potential to treat specific breast cancers. It is indicated for use in androgen receptor-positive triple-negative breast cancer, particularly when the disease has advanced despite prior therapies. Abemaciclib functions by inhibiting proteins known as CDK 4 and 6, which are involved in cell division, thereby slowing cancer cell growth. It belongs to the class of CDK 4/6 inhibitors.

Investigated diseases

Triple Negative Breast Cancer – This is a type of breast cancer that does not have the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER2 protein. It is considered more aggressive and difficult to treat than other types of breast cancer. The disease can progress rapidly, often spreading to other parts of the body. In the context of androgen receptor-positive triple negative breast cancer, the cancer cells may have receptors for androgens, which are male hormones that can influence cancer growth. This subtype may show progression after initial treatments, requiring further therapeutic strategies.