Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Molecular PD-L1 PET/CT Imaging with 89Zr-atezolizumab to Monitor Immune Responses in metastatic Triple Negative Breast Cancer

This study is for people with advanced triple-negative breast cancer. It's looking at a new type of body scan called a PET/CT scan, which uses a special, safe dye called 89Zr-atezolizumab. Researchers want to see how well this new scan identifies specific markers on cancer cells (called PD-L1) compared to a standard biopsy test. PD-L1 is important because it can help doctors decide if certain modern cancer medicines, like Tecentriq, might work. The study also tracks how successful treatments are and how long patients stay well. By comparing these tests, doctors hope to find better ways to monitor and treat this type of breast cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Karolinska University Hospital

Enrolment target

Start

05 Dec 2022

Metastatic triple negative breast cancer

What is this study about?

This research study is focused on a specific type of breast cancer called metastatic triple-negative breast cancer. 'Metastatic' means the cancer has spread to other parts of the body, and 'triple-negative' describes the cancer cells as lacking certain features that other breast cancers have, making it harder to treat with some common therapies.

The main aim of this study is to compare two ways of checking for a specific marker on cancer cells called PD-L1. One way is a standard biopsy test (called IHC), and the other is a new type of scan called a PET/CT scan, which uses a special, very low-dose radioactive dye (called 89Zr-atezolizumab). This dye helps highlight areas where the PD-L1 marker is present. Doctors want to see how well these two methods agree with each other. This is important because knowing if the PD-L1 marker is present can help doctors decide if certain modern cancer medications, like Tecentriq, might be effective.

Beyond just comparing the tests, the study is also looking at important things like how well patients respond to treatment, how long they live without the cancer getting worse (progression-free survival), and if they need to stop treatment for any reason. They will measure these things in different groups of patients, depending on the results of their PD-L1 tests. The overall goal is to improve how we detect and monitor this aggressive form of breast cancer, ultimately leading to better treatment choices for patients.

Key takeaways

The study explores a new scan for advanced triple-negative breast cancer.
It compares a new PET/CT scan method with standard biopsy results.
The goal is to better identify a marker called PD-L1, important for treatment.
Participants will receive standard cancer treatments along with the study tests.
It's a Phase II study, focusing on effectiveness and safety.
The ultimate aim is to improve breast cancer monitoring and treatment decisions.

Who may be eligible?

This study is looking for adults aged 18 or older. Both men and women can take part. To be considered, you must have metastatic triple-negative breast cancer, meaning the breast cancer has spread to other parts of your body, and it doesn't have the three common receptors that some other breast cancers do.

There will be other, more detailed criteria to make sure the study is safe for you and that the results will be clear. For example, your general health, how well your organs are working, and any other medical conditions or treatments you're currently receiving will be carefully checked.

It's important to discuss your full medical history with the study team to find out if this study is a good fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have metastatic triple-negative breast cancer (cancer has spread and lacks three specific markers)?
Are you able to attend regular hospital appointments for treatment and scans?
Are you prepared to discuss your full medical history with the study team?
Are you comfortable with receiving standard cancer medications and undergoing special scans?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive standard cancer treatments including Tecentriq (atezolizumab), carboplatin, and Abraxane (nab-paclitaxel). You will also undergo special imaging tests called PET/CT scans using 89Zr-atezolizumab. These scans will help the researchers compare the new imaging method with standard biopsy results. You'll have regular hospital visits for medication, scans, and check-ups. The study will track how your cancer responds to treatment and your overall health. The specific number of visits and exact duration will depend on your individual treatment plan and how you respond, but there will be ongoing monitoring.

Potential risks and benefits

Taking part in this study could offer several potential benefits. You would receive cutting-edge cancer treatments and close monitoring of your condition, which could lead to better understanding and management of your cancer. The information gathered might also help future patients with triple-negative breast cancer. However, there are potential risks, as with any medical treatment or procedure. The medications used can have side effects, and some people may react to the special dye used in the scans. These risks will be fully explained by the study team. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is triple-negative breast cancer?

It's a type of breast cancer where the cancer cells don't have three common markers. This means it doesn't respond to hormone therapy or treatments that target HER2, making it more challenging to treat.

What is a PET/CT scan?

A PET/CT scan is a special imaging test that combines two types of scans. It helps doctors see how your organs and tissues are working and can detect cancer cells or other problems in the body.

What is PD-L1?

PD-L1 is a protein that can be found on some cancer cells. If cancer cells have PD-L1, it sometimes means they might respond well to certain types of immunotherapy medicines.

Will I get new medicines in this study?

You will receive established cancer treatments (Tecentriq, carboplatin, Abraxane) that are sometimes used for this type of cancer. The new part of the study is the special PET/CT scan and dye, which is being investigated as a tool to better understand your cancer.

What does a 'Phase II' study mean?

A Phase II study is a stage of clinical research that usually involves a small group of people. It aims to see if a new treatment or approach is effective and safe. If the results are promising, it can move on to larger studies.