Actively Recruiting
Assessement of Potential Interest of [68Ga]Ga-PentixaFor PET/CT in Metastatic Triple Negative Breast Cancer Patients
Led by Institut Cancerologie de l'Ouest · Updated on 2026-01-12
12
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessement of Potential Interest of [68Ga]Ga-PentixaFor PET/CT in Metastatic Triple Negative Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent before any study procedures
- Male or female aged 18 years or older at study entry
- Histologically confirmed primary triple negative breast cancer with estrogen and progesterone receptors <10% and HER2 not amplified or overexpressed
- Metastatic breast cancer (recurrence or new) confirmed by [18F]FDG PET/CT or conventional imaging with at least one measurable metastasis
- ECOG performance status less than 2
- Negative pregnancy test for women of childbearing potential before [68Ga]Ga-PentixaFor administration
- Agreement to use contraception for at least 3 months after each [68Ga]Ga-PentixaFor administration
- Adequate organ function as shown by lab tests (specific blood counts and liver function limits)
- Estimated glomerular filtration rate (eGFR) of at least 50 mL/min/1.73m2
- Life expectancy of at least 3 months
- Valid health insurance
- Willingness and ability to comply with study protocol including visits and examinations
You will not qualify if you...
- History of another primary cancer within last 3 years except basal cell carcinoma
- Unable to lie still for at least 1 hour or known claustrophobia
- Serious non-cancer illness that may affect safety or study compliance
- Cognitive impairment affecting ability to consent or follow study requirements
- Pregnant, likely pregnant, or breastfeeding women
- Blood glucose level above 12 mmol/L
- Renal insufficiency with GFR less than or equal to 45 mL/min/1.73 m2
- Known allergy to [68Ga]Ga-PentixaFor or [18F]FDG or their components
- Body weight less than 48 kg
- Persons deprived of liberty or under legal guardianship
- Any condition preventing understanding of trial information or informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institut de cancerologie de l'Ouest
Saint-Herblain, France, 44805
Actively Recruiting
Research Team
C
CAROLINE ROUSSEAU, MD, PhD
CONTACT
N
NADIA ALLAM, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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