Not recruiting

Study on Imaging with 89Zr-Atezolizumab to Monitor Immune Responses in Patients with Metastatic Triple Negative Breast Cancer Using Atezolizumab and Drug Combination

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 metastatic triple-negative breast cancer. This is a form of cancer that has spread to other parts of the body and does not have receptors for estrogen, progesterone, or HER2. The study will use a treatment called atezolizumab, which is a medication designed to help the immune system fight cancer. Atezolizumab will be used in two forms: Tecentriq, which is given as an infusion, and (89Zr)Zr-Atezolizumab, which is used for imaging purposes. Additionally, the study will involve the use of other cancer treatments, including carboplatin and Abraxane (paclitaxel albumin-bound).

The purpose of the study is to monitor how the immune system responds to the cancer using a special imaging technique called PET/CT with (89Zr)Zr-Atezolizumab. This imaging method helps to visualize the presence of a protein called PD-L1 on cancer cells, which is important for understanding how the cancer might respond to treatment. The study will compare this new imaging method with the current standard method, which involves examining a sample of the tumor under a microscope.

Participants in the study will receive the treatments over a period of time, and their response to the treatment will be monitored using the PET/CT imaging. The study aims to see how well the imaging method can predict the effectiveness of the treatment and to understand the progression of the disease. The study will also look at how the cancer responds to the combination of atezolizumab, carboplatin, and Abraxane, and how these treatments affect the spread of cancer in the body.

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
Initial assessment
Upon joining the clinical trial, you will undergo an initial assessment to confirm eligibility. This includes a review of your medical history and a physical examination.
You will need to provide written informed consent, indicating your understanding and agreement to participate in the study.
Step 2
Baseline imaging and biopsy
A baseline PET/CT scan using 89Zr-atezolizumab will be performed to assess the presence of cancerous lesions. This involves an injection of a small amount of radioactive tracer and imaging to visualize the spread of cancer.
A biopsy of at least one metastatic lesion will be conducted to evaluate the PD-L1 status of your cancer.
Step 3
Treatment initiation
You will begin treatment with a combination of medications administered intravenously. This includes atezolizumab, carboplatin, and paclitaxel albumin-bound (also known as Abraxane).
The specific dosage and frequency of these medications will be determined by the study protocol and your treating physician.
Step 4
Ongoing monitoring
Throughout the trial, regular monitoring will be conducted to assess your response to treatment. This includes periodic PET/CT scans and blood tests.
Your health and any side effects experienced will be closely monitored by the study team.
Step 5
Follow-up assessments
At specified intervals, follow-up assessments will be conducted to evaluate the progression of your disease and the effectiveness of the treatment.
These assessments may include additional imaging studies and laboratory tests.
Step 6
Completion of trial
Upon completion of the trial, a final evaluation will be conducted to summarize your overall response to the treatment.
You will receive information about any further steps or treatments recommended based on the trial results.

Who can join the trial?

8 criteria

Patients must have metastatic triple-negative breast cancer. This means the cancer has spread to other parts of the body and the tumor does not have certain hormone receptors.
The cancer must be measurable according to a specific guideline called RECIST v1.1, which is a way to measure how the cancer responds to treatment.
There must be at least one area of cancer that can be safely biopsied, which means a small sample can be taken for testing.
The patient must be considered fit for systemic therapy, which is treatment that affects the whole body, as determined by their doctor.
The patient must have an ECOG performance score of 0 or 1. This is a scale used to assess how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
The patient must be over 18 years old.
The patient must have adequate bone marrow, kidney, and liver function, meaning these organs are working well enough to handle the treatment.
The patient must be able and willing to provide written informed consent, which means they understand the study and agree to participate.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer than metastatic triple negative breast cancer cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are not willing to undergo the required medical tests cannot participate.
Patients who are unable to provide informed consent cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with other serious health conditions that might interfere with the study cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies to the study medication or its components cannot participate.

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Verified sites

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Karolinska University Hospital
Solna, Sweden

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Investigated drugs

89Zr-atezolizumab is a special type of medication used in this clinical trial to help doctors see how the immune system is responding to treatment in patients with a type of breast cancer called metastatic triple negative breast cancer. This medication is combined with a small amount of a radioactive substance, which allows doctors to use a special imaging technique called PET/CT to visualize the presence of a protein called PD-L1 in the body. By doing this, doctors can better understand how the cancer is reacting to the treatment and make more informed decisions about the patient's care.

What is already known about the treatment

Atezolizumab – Atezolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating metastatic triple negative breast cancer, a type of cancer that has spread and lacks certain hormone receptors. The main therapeutic use of atezolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. Atezolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

Investigated diseases

Metastatic Triple Negative Breast Cancer – This is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It is considered more aggressive than other types of breast cancer because it grows and spreads faster. The disease progresses as cancer cells spread beyond the breast to other parts of the body, such as the bones, liver, or lungs. It is characterized by the absence of targeted receptors, making it unresponsive to some of the hormonal therapies used in other breast cancer types. The progression involves the development of tumors in distant organs, which can lead to various symptoms depending on the organs affected. The spread of cancer cells to other parts of the body is known as metastasis, which is a key feature of this disease.