Assessement of Potential Interest of [68Ga]Ga-PentixaFor PET/CT in Metastatic Triple Negative Breast Cancer Patients

NCT06962163 | Recruiting

• 1 other identifier: ICO-2023-17
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer; Triple negative breast cancer; [68Ga]Ga-PentixaFor PET/CT; [18F]FDG PET/CT; CXCR4

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Secondary Outcomes (6)

• 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

  36 months

• 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

  1 day

• 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

  36 months

• 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).

  36 months

• To assess the correlation between the standard uptake values (SUV) of [68Ga]Ga-PentixaFor and CXCR4 expression by IHC assessment on primitive and/or metastatic tumour samples at screening and at disease progression if a biopsy is performed

  36 months

Other Outcomes (1)

• To assess the prognostic value of serum FLT3-Ligand in relapsing Triple Negative Breast Cancer patients

  36 months

Study Arms (1)

[68Ga]Ga-PentixaFor

EXPERIMENTAL

2 \[68Ga\]Ga-PentixaFor PET-CT are performed after patient inclusion and at disease progression.

Diagnostic Test: [68Ga]Ga-PentixaFor PET/CT

Interventions

[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.

[68Ga]Ga-PentixaFor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Primitive triple negative breast cancer proven histologically, defined according to the following criteria:
• Estrogen receptors \<10%.
• And progesterone receptors \<10%.
• And HER2 not amplified or not overexpressed.
• Recurrence metastatic Breast Cancer or De Novo metastatic Breast Cancer documented by \[18F\]FDG PET/CT ± conventional imaging with at least one measurable metastasis according to PERCIST and/or RECIST.
• ECOG performance status \< 2.
• Negative serum/urine pregnancy test prior to \[68Ga\]Ga-PentixaFor administration for female patient of childbearing potential\*.
• Consent to use a contraception method for at least 3 months after each administration of \[68Ga\]Ga-PentixaFor (as defined in Appendix 7 and according to local guidelines).
• Adequate Organ function confirmed by laboratory tests results allowing for safe administration of \[68Ga\]Ga- PentixaFor:
• Hematologic function: Absolute Neutrophil Count (ANC) of ≥ 1.5 x 109 /L, platelet count of ≥ 100 x 109 /L, and hemoglobin of ≥ 9 g/dL).
• Hepatic function: AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastases).
• Renal function: Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min/1.73m², as calculated using the CKD-EPI or MDRD equation.Life expectancy at least 3 months.
• Patient has valid health insurance.

You may not qualify if:

• 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.
• Pregnant, likely to be pregnant or breastfeeding woman.
• Blood glucose \> 12mmol/L.
• Renal insufficiency with GFR ≤ 45 mL/min/ 1.73 m².
• Known hypersensitivity to any active pharmaceutical agent or constituent of the \[68Ga\]Ga-PentixaFor and/or \[18F\]FDG product.
• Body weight of less than 48 kg.
• Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.
• Disorder precluding understanding of trial information or informed consent.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de cancerologie de l'Ouest

Saint-Herblain, 44805, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• CAROLINE ROUSSEAU, MD, PhD

  Institut de Cancérologie de l'Ouest (ICO)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CAROLINE ROUSSEAU, MD, PhD

CONTACT

+33 2 40 67 99 31; Caroline.Rousseau@ico.unicancer.fr

NADIA ALLAM, PhD

CONTACT

+33 2 40 67 98 26; nadia.allam@ico.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: \[68Ga\]Ga-PentixaFor PET-CT

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2030
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)