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Study on Pembrolizumab with Chemotherapy for Early-Stage Triple-Negative Breast Cancer in Patients with High TILs

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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 the treatment of triple-negative breast cancer, a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth. The study will explore the effects of combining a medication called pembrolizumab (also known as Keytruda) with different chemotherapy regimens. Pembrolizumab is an immunotherapy drug that helps the immune system fight cancer. The chemotherapy drugs being studied include doxorubicin hydrochloride, epirubicin hydrochloride, paclitaxel, carboplatin, and cyclophosphamide. Additionally, filgrastim and glatiramer acetate are included in the study to support the immune system during treatment.

The purpose of this study is to compare how the immune system is activated when different chemotherapy drugs are used alongside pembrolizumab in the treatment of early-stage, high-risk triple-negative breast cancer. The study will involve a pre-surgical treatment phase, where patients will receive one of the chemotherapy regimens combined with pembrolizumab. The treatment will be administered over a period of several months, and the response to the treatment will be monitored through medical imaging and other assessments. If there is a complete response, surgery may be performed earlier, followed by additional treatment to ensure safety.

Participants will receive treatment through intravenous infusions or subcutaneous injections, depending on the specific medication. The study aims to identify the most effective combination of pembrolizumab and chemotherapy for activating the immune system and achieving a complete response in patients with triple-negative breast cancer. The trial will also evaluate the changes in specific immune cells within the tumor before and after treatment. This research is important for understanding how to best use pembrolizumab in combination with chemotherapy to treat this aggressive form of breast cancer.

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 treatment phase
The treatment begins with the administration of pembrolizumab through an intravenous infusion. This medication is given to help activate the immune system against cancer cells.
Alongside pembrolizumab, chemotherapy drugs such as doxorubicin hydrochloride and epirubicin hydrochloride are administered via intravenous infusion. These drugs are part of the anthracycline group, which helps to kill cancer cells.
The frequency and dosage of these medications will be determined by the healthcare provider based on individual patient needs and response to treatment.
Step 2
Combination chemotherapy phase
In this phase, a combination of carboplatin and paclitaxel is administered through intravenous infusion. These drugs work together to stop the growth of cancer cells.
The treatment schedule, including the frequency and dosage, will be tailored to the patient's specific condition and response to the therapy.
Step 3
Supportive care phase
To support the immune system and reduce the risk of infection, filgrastim or pegfilgrastim is given as a subcutaneous injection. These medications help increase white blood cell counts.
The administration of these supportive medications is based on the patient's blood test results and overall health status.
Step 4
Monitoring and evaluation phase
Throughout the trial, regular monitoring of the patient's health and response to treatment is conducted. This includes blood tests, imaging studies, and physical examinations.
The primary goal is to assess the effectiveness of the treatment in achieving a pathological complete response, which means no signs of cancer in tissue samples after treatment.
Step 5
Follow-up phase
After completing the treatment regimen, follow-up visits are scheduled to monitor the patient's recovery and long-term health outcomes.
These visits may include additional tests and assessments to ensure the cancer has not returned and to manage any side effects from the treatment.

Who can join the trial?

11 criteria

Be willing and able to provide written informed consent for the trial.
Male participants must agree to use contraception during the treatment period and for at least 12 months after the last dose of cyclophosphamide or 6 months after the last chemotherapy, whichever is longer. They should also refrain from donating sperm during this time.
Female participants must not be pregnant or breastfeeding. They must either not be of childbearing potential or agree to use contraception during the treatment period and for at least 12 months after the last dose of cyclophosphamide or 6 months after the last chemotherapy, whichever is longer.
Participants must be at least 18 years old on the day of signing the informed consent.
Have a confirmed diagnosis of invasive breast cancer classified as **triple negative breast cancer (TNBC)**, which means the cancer does not have certain receptors that are common in other breast cancers.
Have a tumor with **tumor infiltrating lymphocytes (TILs)** equal to or above 10%. TILs are immune cells present in the tumor.
Have previously untreated non-metastatic TNBC, meaning the cancer has not spread to other parts of the body. The cancer should meet specific size and lymph node involvement criteria.
Provide a core needle biopsy, which is a sample of the tumor, consisting of at least 3 separate tumor cores from the primary tumor at screening. Be willing to provide a second biopsy at the end of the first cycle of treatment.
Have an **Eastern Cooperative Oncology Group (ECOG) performance status** of 0 or 1, which indicates the participant is fully active or has some symptoms but can carry out light work.
Have a **left ventricular ejection fraction (LVEF)** of 50% or higher, which is a measure of how well the heart is pumping blood, as assessed by an echocardiogram or a similar test.
Have adequate organ function as defined in the study protocol, with tests done within 28 days before starting the study treatment.

Who cannot join the trial?

5 criteria

Patients who have a different type of breast cancer than the one being studied cannot participate.
Patients who do not have a certain level of immune cells called TILs (tumor-infiltrating lymphocytes) in their tumor cannot participate. TILs are immune cells that have moved into the tumor.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not female or male, as specified by the study, cannot participate.
Patients who are considered part of a vulnerable population, which means they might need special protection or care, cannot participate.

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Verified sites

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Unidade Local De Saúde De Santa Maria, E.P.E.
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Lisbon, Portugal

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Investigated drugs

Keytruda
This medication is used to help the immune system detect and fight cancer cells. It is often used in combination with other treatments to enhance its effectiveness, particularly in certain types of breast cancer.
Anthracycline
This is a type of chemotherapy that works by interfering with the DNA inside cancer cells, preventing them from growing and dividing. It is commonly used to treat various types of cancer, including breast cancer.
Carboplatin
This chemotherapy drug is used to treat different types of cancer by damaging the DNA of cancer cells, which stops them from multiplying. It is often used in combination with other chemotherapy drugs.
Paclitaxel
This is a chemotherapy medication that works by stopping cancer cells from dividing. It is used to treat a variety of cancers, including breast cancer, and is often part of a combination therapy.

What is already known about the treatment

Keytruda – Keytruda is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently well-established in medical literature as an immunotherapy treatment for various cancers, including high-risk triple-negative breast cancer. The main therapeutic indication for Keytruda in this context is to enhance the immune system's ability to fight cancer cells. At the molecular level, Keytruda works by blocking the PD-1 pathway, which cancer cells use to hide from the immune system, thereby allowing T cells to detect and attack the cancer. It is classified as a monoclonal antibody and is part of the broader category of immune checkpoint 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 HER-2/neu gene. It is considered more aggressive and difficult to treat than other types of breast cancer. The disease often grows and spreads faster, has fewer treatment options, and tends to have a worse prognosis. It is more common in women under 40, African American women, and those with a BRCA1 mutation. The progression of this cancer can vary, but it often involves rapid growth and a higher likelihood of spreading to other parts of the body.