CXCR4-targeted [68Ga]Ga-PentixaFor PET/CT imaging for metastatic triple-negative breast cancer
Prospective Phase 0 Pilot Study, Assessing Potential Interest of [68Ga]Ga-PentixaFor PET/CT in Metastatic Triple Negative Breast Cancer Patients
This study will test whether a CXCR4-targeted PET/CT scan ([68Ga]Ga-PentixaFor) can better detect metastatic triple-negative breast cancer than the standard [18F]FDG PET/CT in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Cancerologie de l'Ouest Academic / other |
| Locations | 1 site (Saint-Herblain) |
| Trial ID | NCT06962163 on ClinicalTrials.gov |
What this trial studies
The trial uses a CXCR4-targeted radiotracer, [68Ga]Ga-PentixaFor, with PET/CT to image metastatic triple-negative breast cancer. Adults with histologically confirmed TNBC and at least one measurable metastasis will undergo [68Ga]Ga-PentixaFor PET/CT and findings will be compared with prior [18F]FDG PET/CT and conventional imaging. The aim is to see if CXCR4 imaging identifies additional lesions or different uptake patterns that could change staging or treatment planning. Participants must give informed consent, have ECOG performance status <2, and meet pregnancy and contraception requirements.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed triple-negative metastatic breast cancer and at least one measurable metastasis on prior imaging, with ECOG performance status below 2, are eligible.
Not a fit: Patients whose tumors do not express CXCR4 or who cannot undergo PET/CT (for example, pregnant patients or those with prohibitive comorbidity) are unlikely to benefit diagnostically.
Why it matters
Potential benefit: If successful, this imaging approach could improve detection of metastatic sites and help guide personalized treatment decisions for TNBC patients.
How similar studies have performed: CXCR4-targeted imaging has shown promising results in other cancers and preclinical models, but clinical data specifically in metastatic TNBC are limited and the approach remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
2. Female or male, Age ≥ 18 years at time of study entry.
3. 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.
4. 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.
5. ECOG performance status \< 2.
6. Negative serum/urine pregnancy test prior to \[68Ga\]Ga-PentixaFor administration for female patient of childbearing potential\*.
7. 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).
8. 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).
9. 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.
10. Patient has valid health insurance.
11. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
* Note: a female participant of childbearing potential is a woman who is not permanently sterilized or not postmenopausal (postmenopausal is defined as 12 months with no menses without an alternative medical cause).
Exclusion Criteria:
1. History of another primary malignancy within the last 3 years before study entry except for basal cell carcinoma.
2. Impossibility to hold lying motionless at least 1 hour, or known claustrophobia.
3. 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.
4. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
5. Pregnant, likely to be pregnant or breastfeeding woman.
6. Blood glucose \> 12mmol/L.
7. Renal insufficiency with GFR ≤ 45 mL/min/ 1.73 m².
8. Known hypersensitivity to any active pharmaceutical agent or constituent of the \[68Ga\]Ga-PentixaFor and/or \[18F\]FDG product.
9. Body weight of less than 48 kg.
10. Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.
11. Disorder precluding understanding of trial information or informed consent.
Where this trial is running
Saint-Herblain
- Institut de cancerologie de l'Ouest — Saint-Herblain, France (Recruiting)
Study contacts
- Principal investigator: CAROLINE ROUSSEAU, MD, PhD — Institut de Cancérologie de l'Ouest (ICO)
- Study coordinator: CAROLINE ROUSSEAU, MD, PhD
- Email: Caroline.Rousseau@ico.unicancer.fr
- Phone: +33 2 40 67 99 31
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.