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Study of Pembrolizumab and Cyclophosphamide for Patients with Inflammatory Breast Cancer on the Chest Wall

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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 inflammatory breast cancer that has spread to the chest wall. The study involves two treatments: pembrolizumab, which is a medication that helps the immune system fight cancer, and cyclophosphamide, a chemotherapy drug taken in low doses over a long period. The purpose of the study is to assess how effective these treatments are when used together in patients with this specific type of breast cancer.

Participants in the study will receive both pembrolizumab and cyclophosphamide. Pembrolizumab is given as an infusion, which means it is delivered directly into the bloodstream through a vein, while cyclophosphamide is taken orally as a tablet. The study will last for a period of up to 24 months, during which the effects of the treatment will be monitored. Some participants may receive a placebo instead of one of the medications to help researchers compare the results.

The study aims to understand how well the combination of these treatments works in controlling the cancer and improving the patients' quality of life. Researchers will look at various outcomes, such as how long patients live without the cancer getting worse and how long the response to the treatment lasts. This information will help determine the potential benefits of using pembrolizumab and cyclophosphamide together for treating inflammatory breast cancer that has spread to the chest wall.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
A series of laboratory tests are performed to ensure adequate organ function. These tests must be completed within 10 days before starting treatment.
A pregnancy test is required for female participants of childbearing potential within 72 hours before the first dose of medication.
Step 2
Biopsy and imaging
A biopsy is performed to obtain tissue for PD-L1 biomarker analysis. This is mandatory for enrollment.
Imaging tests are conducted to measure metastatic disease based on specific criteria. These tests help in tracking the disease's progression.
Step 3
Treatment initiation
Treatment begins with the administration of pembrolizumab and metronomic cyclophosphamide.
Pembrolizumab is given as an intravenous infusion. The specific dosage and frequency are determined by the study protocol.
Cyclophosphamide is taken orally in the form of coated tablets. The dosage and frequency are also specified in the study protocol.
Step 4
Ongoing monitoring
Regular follow-up visits are scheduled to monitor the response to treatment and any side effects.
Additional imaging tests are performed periodically to assess the disease's response to the treatment.
Step 5
Completion of treatment
The treatment phase continues until the study's end date or until the disease progresses, whichever comes first.
Upon completion, a final assessment is conducted to evaluate the overall response to the treatment.

Who can join the trial?

16 criteria

The patient must have a specific type of breast cancer that has spread to the chest wall and cannot be removed by surgery.
The cancer must be confirmed by a test called a biopsy, and it should show certain markers like **PDL1** or **tumor infiltrating lymphocytes**.
The patient should have already received treatments like chemotherapy or radiation therapy.
The patient must have a **performance status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
Female patients who can have children must use birth control during the study and for 120 days after the last dose of the study medication.
Male patients must also agree to use birth control during the study and for 120 days after the last dose of the study medication.
If abstinence is the usual lifestyle, it is acceptable as a form of birth control.
Female patients must have a negative pregnancy test before starting the study medication.
Patients with certain types of breast cancer that do not respond to hormonal or anti-HER2 treatments may be eligible.
The patient must have normal organ function based on lab tests done within 10 days before starting treatment.
The patient must have tissue available for repeated biopsies.
The patient should be expected to live for more than 3 months.
The patient must be willing to sign a consent form to participate in the study.
The patient must be at least 18 years old.
The patient must have provided a tissue sample for a **PD-L1 biomarker** test from a recent biopsy.
The patient must have measurable cancer that has spread, as determined by specific imaging criteria.

Who cannot join the trial?

10 criteria

Patients who have had a recent heart attack or severe heart problems.
Patients with active infections that require treatment with antibiotics.
Patients who are pregnant or breastfeeding.
Patients with another type of cancer that is not under control.
Patients who have had an organ transplant.
Patients with a known allergy to the study drugs.
Patients who are currently participating in another clinical trial.
Patients with severe liver or kidney disease.
Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body.
Patients who have received certain vaccines within a specific time frame before the study.

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Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

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Investigated drugs

Pembrolizumab
is a type of immunotherapy that helps the body's immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells.
Metronomic Cyclophosphamide
is a chemotherapy drug used in a low-dose, continuous manner. This approach aims to minimize side effects while still effectively targeting cancer cells. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

What is already known about the treatment

Pembrolizumab
This medication is administered as an intravenous infusion. It is currently used in medicine for various types of cancer, including breast cancer, and is well-documented in medical literature. The main therapeutic indication for pembrolizumab in this trial is for patients with locally recurrent, inoperable, and/or metastatic inflammatory breast cancer with lymphangitic spread to the chest wall. At the molecular level, pembrolizumab works by blocking a protein called PD-1 on immune cells, which helps the immune system attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor.
Cyclophosphamide
This medication is taken orally in a metronomic dosing schedule, meaning it is given in low, regular doses. It is a well-established drug in the treatment of various cancers and is frequently mentioned in medical literature. In this trial, cyclophosphamide is used for patients with breast cancer that has spread to the chest wall. Its mechanism of action involves interfering with the DNA of cancer cells, preventing them from dividing and growing. Cyclophosphamide is classified as an alkylating agent.

Investigated diseases

Inflammatory Breast Cancer – This is a rare and aggressive form of breast cancer that often presents with redness and swelling of the breast, resembling an infection. It progresses rapidly, with cancer cells blocking lymph vessels in the skin of the breast, leading to symptoms such as warmth, tenderness, and a pitted appearance of the skin. Unlike other breast cancers, it may not form a distinct lump and can spread quickly to nearby lymph nodes and other parts of the body. In some cases, it can become locally recurrent, meaning it returns to the same area after treatment. It can also become inoperable, indicating that surgery is not a viable option due to the extent of the disease. Additionally, it may metastasize, spreading to other parts of the body, including the chest wall, where it can cause further complications.