Triple-negative breast cancer (TNBC) is a particularly aggressive type of breast cancer that is difficult to treat. Unlike other forms of breast cancer, TNBC tends to relapse earlier and spread more quickly to other parts of the body. Unfortunately, patients with TNBC have a lower survival rate, often less than five years after diagnosis. This highlights the urgent need for better treatments for TNBC.
One of the main challenges in treating TNBC is that it lacks certain receptors that other breast cancers have. These receptors are usually targeted by specific therapies, making TNBC harder to treat with targeted approaches.
Currently, a type of imaging called \[18F\]FDG PET/CT is the most accurate method for detecting breast cancer and its spread. However, with the rise of personalized medicine, there is a growing interest in molecular targeted approaches. These methods aim to provide highly specific diagnostics and treatments based on the unique characteristics of each patient's cancer.
One promising target for these new approaches is a receptor called CXCR4. CXCR4 is found on the surface of many cells and is involved in various processes in the body. It is often overexpressed in different types of cancer, including breast cancer. Research has shown that CXCR4 levels are higher in metastatic sites (where cancer has spread) compared to primary tumors. CXCR4 is not only present in cancer cells but also in immune cells within the tumor environment.
In invasive breast cancer, CXCR4 plays a crucial role in tumor migration, invasiveness, metastasis, and proliferation. A clinical study evaluated 18 breast cancer patients using a new imaging method called \[68Ga\]Ga-PentixaFor PET/CT or PET/MR. They found that this method showed higher uptake in breast cancer cases with poorer prognosis compared to the traditional \[18F\]FDG PET/CT. Higher CXCR4 expression is particularly seen in TNBC compared to other breast cancer subtypes.
The goal of the study is to assess how \[68Ga\]Ga-PentixaFor is distributed in the body using PET/CT imaging. This will help demonstrate the potential of CXCR4 as a promising target for new treatments. If successful, \[68Ga\]Ga-PentixaFor PET/CT could become a valuable tool for identifying patients who might benefit from treatments using \[177Lu\]/\[90Y\] PentixaTher.
Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
Female or male, Age ≥ 18 years at time of study entry.
Estrogen receptors <10%.
And progesterone receptors <10%.
History of another primary malignancy within the last 3 years before study entry except for basal cell carcinoma.
Impossibility to hold lying motionless at least 1 hour, or known claustrophobia.
Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator.
Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
Single group
[68Ga]Ga-PentixaFor PET/CT
Diagnostic test\[68Ga\]Ga-PentixaFor PET-CT is performed after patient inclusion. The patient is treated as per standard of care until disease progression. Then another \[68Ga\]Ga-PentixaFor PET-CT is performed.
To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and [18F]FDG PET/CT based on a lesion-by-lesion basis analysis performed at patient inclusion
Concordance study of metastatic uptake seen in \[18F\]FDG PET/CT scan and \[68Ga\]Ga-PentixaFor PET/CT scan per "lesion" by comparing for each lesion the \[18F\]FDG PET scan and \[68Ga\]Ga-PentixaFor PET/CT scan by assessing a ratio "Number of positive or negative \[68Ga\]Ga-PentixaFor lesions / Number of positive or negative FDG lesions" performed at patient inclusion
To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and [18F]FDG PET/CT based on a lesion-by-lesion basis analysis performed at disease progression
Concordance study of metastatic uptake seen in \[18F\]FDG PET/CT scan and \[68Ga\]Ga-PentixaFor PET/CT scan per "lesion" by comparing for each lesion the \[18F\]FDG PET/CT scan and \[68Ga\]Ga-PentixaFor PET/CT scan by assessing a ratio "Number of positive or negative \[68Ga\]Ga-PentixaFor lesions / Number of positive or negative FDG lesions" performed at disease progression
To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and conventional imaging CT scan based on a lesion-by-lesion basis analysis performed at patient inclusion
Conventional imaging (CT scan), and \[68Ga\]Ga-PentixaFor PET/CT will be analysed for each lesion, obtaining a ratio of number of \[68Ga\]Ga-PentixaFor(+) lesions / number of CT scan lesions" at patient inclusion
To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and conventional imaging: CT scan based on a lesion-by-lesion basis analysis performed at disease progression
Conventional imaging: CT scan, and \[68Ga\]Ga-PentixaFor PET/CT will be analysed for each lesion, obtaining a ratio of number of \[68Ga\]Ga-PentixaFor(+) lesions / number of CT scan lesions" at disease progression
To determine the percentage of total tumour burden (whole body) detected on [68Ga]Ga-PentixaFor PET/CT compared to that defined on [18F]FDG PET/CT (considered as reference).
Percentage of \[68Ga\]Ga-PentixaFor(+) metastatic tumour burden compared to total metastatic tumour burden by \[18F\]FDG PET/CT
To assess the prognostic value of serum FLT3-Ligand in relapsing Triple Negative Breast Cancer patients
Plasma FLT3-Ligand dosage will be performed at screening, every 3 months during treatment period and at disease progression follow-up visit for all patients. The relationship between FLT3-Ligand levels and patient outcomes (OS and DFS) will be analysed using Kaplan-Meier survival analysis and univariable Cox analysis
Click on the lead sponsor to view all of their trials.
