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Study of Atezolizumab, Carboplatin, and Nab-Paclitaxel for Patients with Metastatic Triple-Negative PD-L1 Positive 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 metastatic triple-negative PD-L1 positive breast cancer. This is a form of breast cancer that has spread to other parts of the body and does not have certain receptors that are commonly found in other breast cancers. The study is testing a combination of three treatments: atezolizumab, carboplatin, and paclitaxel albumin-bound. Atezolizumab is a type of medicine called a monoclonal antibody, which helps the immune system fight cancer. Carboplatin and paclitaxel albumin-bound are chemotherapy drugs that help stop the growth of cancer cells.

The purpose of this study is to gather preliminary evidence on how effective this combination of treatments is as a first-line therapy, meaning it is the first treatment given for this type of cancer. Participants in the study will receive these medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will last for up to 12 months, during which time the effects of the treatment will be monitored. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

The study aims to understand how well patients respond to this treatment combination and how it affects their overall survival over a period of two years. The trial will also look at other factors, such as the time it takes for the disease to progress and any side effects experienced by participants. This information will help determine if this combination of treatments can be an effective option for patients with this specific type of breast cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
The treatment begins with the administration of three medications: paclitaxel albumin-bound, carboplatin, and atezolizumab. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.
The specific dosage and frequency of these medications will be determined by the healthcare provider based on individual patient needs and the study protocol.
Step 2
Treatment cycle
The treatment is organized into cycles. Each cycle includes the administration of the medications followed by a period of rest to allow the body to recover.
The duration of each cycle and the number of cycles will be specified by the healthcare provider.
Step 3
Monitoring and assessments
Regular monitoring and assessments are conducted to evaluate the response to the treatment and to check for any side effects.
These assessments may include physical examinations, blood tests, and imaging studies.
Step 4
Completion of treatment
The treatment continues until the healthcare provider determines that the patient has completed the necessary number of cycles or if any adjustments are needed based on the patient's response.
The estimated end date for the trial is December 11, 2025.

Who can join the trial?

20 criteria

Must sign an Informed Consent Form, which is a document that explains the study and confirms your agreement to participate.
Previous chemotherapy with certain drugs (taxanes and/or carboplatin) for early breast cancer is allowed if it was completed at least 12 months before joining the study.
Previous treatment with immune checkpoint inhibitors for early breast cancer is allowed if it was completed at least 12 months before joining the study.
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 a life expectancy of at least 12 weeks.
Must have a disease that can be measured or evaluated according to specific guidelines (RECIST v1.1).
Must have adequate blood and organ function, confirmed by lab tests done within 2 weeks before starting the study treatment.
Must have a negative test for HIV (human immunodeficiency virus) at screening.
Must have a negative test for hepatitis B at screening, or if positive for certain antibodies, a negative test for the virus itself.
Must have a negative test for hepatitis C at screening, or if positive for antibodies, a negative test for the virus itself.
Must be 18 years or older.
Women who can have children must agree to use a reliable birth control method or remain abstinent during the study and for a certain period after the last dose of study drugs.
Women who can have children must have a negative pregnancy test within 7 days before starting the study drug.
Men must agree to use birth control or remain abstinent and not donate sperm during the study.
Must have a confirmed diagnosis of a specific type of breast cancer (adenocarcinoma) that has spread to other parts of the body.
Must have breast cancer that is hormone receptor-negative and HER2-negative, based on tests done on the primary tumor or a biopsy of the metastatic disease.
Must have breast cancer that is PD-L1 positive, meaning a certain protein is present on immune cells in the tumor, based on tests done on the primary tumor or a biopsy of the metastatic disease.
Must provide a sample of the tumor for research purposes.
Must be eligible for first-line chemotherapy with taxane and carboplatin drugs.
Must not have had prior chemotherapy or targeted therapy for advanced or metastatic triple-negative breast cancer. Previous radiation therapy for metastatic disease is allowed, but you should have recovered from its effects before joining the study.

Who cannot join the trial?

7 criteria

Patients who do not have **metastatic triple-negative PD-L1 positive breast cancer** cannot participate. This type of cancer is a specific form of breast cancer that has spread to other parts of the body and lacks certain receptors.
Patients who have received previous treatments for their cancer may not be eligible, as the study is looking at the effects of the treatment as a first-line therapy, meaning it is the first treatment given for the cancer.
Patients who are not within the specified age range for the study may be excluded. The study may have specific age requirements.
Patients who are not able to follow the study procedures or attend the required visits may not be eligible.
Patients with other serious health conditions that could interfere with the study treatment or outcomes may be excluded.
Patients who are pregnant or breastfeeding may not be eligible to participate in the study.
Patients who are participating in another clinical trial at the same time may not be eligible.

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Verified sites

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

Azienda Ospedaliera Ordine Mauriziano Di Torino
Responsive
Turin, Italy
Azienda Ospedaliero Universitaria Di Sassari
Responsive
Sassari, Italy
Azienda Ospedaliero Universitaria Parma
Responsive
Parma, Italy

Trial locations

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Investigated drugs

Atezolizumab
is a medication used in this trial to help the immune system attack cancer cells. It works by blocking a protein that stops the immune system from working properly, allowing it to better target and destroy cancer cells.
Carboplatin
is a chemotherapy drug used to treat various types of cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing, ultimately leading to their death.
Nab-paclitaxel
is another chemotherapy medication used in this trial. It is a form of paclitaxel that is bound to a protein called albumin, which helps it to be absorbed by the body more effectively. It works by stopping cancer cells from dividing, which slows down or stops the growth of the cancer.

What is already known about the treatment

Atezolizumab
Atezolizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic triple-negative PD-L1 positive breast cancer. It is an approved medication in the field of oncology, with ongoing research to expand its therapeutic applications. The main therapeutic indication for atezolizumab is as a first-line treatment for certain types of cancer, including the specified breast cancer subtype. At the molecular level, atezolizumab works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.
Carboplatin
Carboplatin is given intravenously and is widely used in cancer treatment, with a well-established role in chemotherapy regimens. It is currently being evaluated in combination with other drugs for its efficacy in treating metastatic triple-negative PD-L1 positive breast cancer. The primary therapeutic use of carboplatin is to treat various types of cancer, including ovarian, lung, and breast cancer. Its mechanism of action involves binding to DNA and interfering with the cancer cell's ability to divide and grow. Carboplatin is classified as a platinum-based chemotherapy agent.
Nab-Paclitaxel
Nab-paclitaxel is administered intravenously and is a formulation of the chemotherapy drug paclitaxel, bound to albumin nanoparticles. It is approved for use in treating breast cancer and is being studied in combination with other drugs for metastatic triple-negative PD-L1 positive breast cancer. The main therapeutic indication is for the treatment of breast cancer, among other cancers. Nab-paclitaxel works by stabilizing microtubules, which inhibits cell division and leads to cancer cell death. It is classified as a taxane chemotherapy agent.

Investigated diseases

Metastatic Triple-Negative PD-L1 Positive Breast Cancer – This is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growths: estrogen, progesterone, and HER2/neu. It is characterized by the presence of the PD-L1 protein, which can help the cancer evade the immune system. The cancer is considered metastatic when it has spread beyond the breast to other parts of the body. This type of breast cancer tends to grow and spread more quickly than other forms. It is often diagnosed at a later stage due to its aggressive nature. The progression of the disease can vary, but it typically involves the rapid spread to other organs.