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Study on 68Ga-FAPI-46 for Predicting Treatment Response in Early-Stage High-Risk Triple-Negative Breast Cancer Patients Undergoing Chemo-Immunotherapy

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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 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 use a special imaging technique called 68Ga-FAPI-46 PET/CT to predict how well patients respond to a combination of chemotherapy and a medication called pembrolizumab. Pembrolizumab is a type of immunotherapy that helps the immune system fight cancer. The purpose of the study is to see if the imaging can accurately predict the response to this treatment in patients with early-stage, high-risk triple-negative breast cancer.

Participants in the study will undergo the 68Ga-FAPI-46 PET/CT scan before starting their treatment. This scan is designed to measure a specific biomarker in the tumor, which may help predict how the cancer will respond to the treatment. The treatment involves a combination of chemotherapy drugs, including paclitaxel, cyclophosphamide, epirubicin, doxorubicin, and carboplatin, along with pembrolizumab. Some patients may receive a placebo instead of pembrolizumab. The study will compare the results of the 68Ga-FAPI-46 PET/CT scan with another type of scan called 18F-FDG PET/CT to see which is more effective in predicting treatment outcomes.

The trial will also explore how the imaging results correlate with other factors, such as the presence of certain proteins in the tumor and the amount of circulating tumor DNA in the blood. This information could help improve the understanding of how triple-negative breast cancer responds to treatment and potentially lead to better treatment strategies in the future. The study is expected to continue until 2029, with recruitment starting in 2024.

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 imaging
Undergo a 68Ga-FAPI-46 PET/CT scan. This imaging test helps to assess the tumor burden and predict the response to treatment.
The scan involves the use of a radioactive tracer, 68Ga-FAPI-46, administered through an intravenous infusion.
Step 2
Neoadjuvant treatment
Receive a combination of chemotherapy and immunotherapy before surgery. This is known as neoadjuvant treatment.
The chemotherapy regimen includes paclitaxel, cyclophosphamide, epirubicin hydrochloride, doxorubicin hydrochloride, and carboplatin. These medications are administered through intravenous infusions.
Additionally, pembrolizumab, an immunotherapy drug, is given as an infusion to help the immune system fight cancer cells.
Step 3
Follow-up imaging
Undergo another 68Ga-FAPI-46 PET/CT scan to evaluate the response to the neoadjuvant treatment.
This scan helps to determine the effectiveness of the treatment in reducing the tumor size and burden.
Step 4
Surgical intervention
Proceed with surgery to remove the tumor. The timing and type of surgery depend on the response to the neoadjuvant treatment.
The surgical procedure aims to remove any remaining cancerous tissue.
Step 5
Post-surgery evaluation
After surgery, the removed tissue is examined to assess the histological response to the treatment.
This evaluation helps to confirm the effectiveness of the neoadjuvant therapy in eliminating cancer cells.
Step 6
Long-term follow-up
Participate in regular follow-up visits to monitor health and detect any signs of cancer recurrence.
These visits may include physical examinations, imaging tests, and laboratory tests as needed.

Who can join the trial?

8 criteria

Must be a female who is at least 18 years old.
Must have triple-negative breast cancer (TNBC) that has not been treated before and has not spread to other parts of the body. The cancer should be confirmed by a central lab and be at a specific stage (T1c N1-2 or T2-4 N0-2) according to the American Joint Committee on Cancer (AJCC) guidelines. The recommended treatment should be chemotherapy plus pembrolizumab.
Must have cancer that can be measured using specific criteria called RECIST/PERCIST.
Must not have cancer that has spread to distant parts of the body, confirmed by a specific type of scan called 18F-FDG PET/CT.
Must have a sample of the tumor tissue available for study.
Must have signed a written form agreeing to participate in the study, known as informed consent.
Must be able to follow the study's rules and requirements.
Must have health insurance coverage.

Who cannot join the trial?

6 criteria

Patients who are not diagnosed with **breast cancer** cannot participate.
Patients who are not in the early stages of **high-risk TNBC** (a type of breast cancer) are excluded.
Patients who are not undergoing **neoadjuvant chemotherapy** (treatment given before the main treatment) plus **pembrolizumab** (a type of medication) are excluded.
Patients who are not within the specified age range for the study cannot participate.
Patients who do not meet the gender requirements for the study are excluded.
Patients who are part of a vulnerable population are not eligible for the study.

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Verified sites

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Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, France
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Institut Curie
Paris, France

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Investigated drugs

68Ga-FAPI-46
is a special imaging agent used in PET/CT scans. It helps doctors see certain features of tumors in patients with triple-negative breast cancer. This imaging agent is used to predict how well a tumor might respond to treatment.
Pembrolizumab
is a type of immunotherapy. It helps the body's immune system recognize and attack cancer cells. In this trial, it is used alongside chemotherapy to treat patients with triple-negative breast cancer.

What is already known about the treatment

68Ga-FAPI-46 – This medication is administered through an intravenous injection and is used in PET/CT imaging. It is currently being studied in clinical trials to assess its effectiveness in predicting the response of triple-negative breast cancer to neoadjuvant chemo-immunotherapy. The main therapeutic indication is for imaging in breast cancer, specifically to evaluate tumor burden. At the molecular level, it targets fibroblast activation protein (FAP) expressed in cancer-associated fibroblasts, allowing for precise imaging of tumors. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump or seen on an imaging test. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some types growing slowly and others more rapidly. Early-stage breast cancer may not cause noticeable symptoms, but as it advances, it can lead to changes in breast shape, size, or appearance, and sometimes pain. The disease is categorized into different types based on hormone receptor status and other factors, which can influence its behavior and progression.