ProspectivE phase 0 pilot study, assessing potential prognostic and theranostic interest of 68Ga-PentiXafor PET-CT In metastatic triple neGative brEast caNCer patiEnts (EXIGENCE)

Prior treatment

• Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first [68Ga]Ga-PTF administration

Other illness

• History of another primary malignancy within the last 3 years except for basal cell carcinoma.
• Disorder precluding understanding of trial information or informed consent
• 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
• Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PentixaFor and/or [18F]FDG product

Lab values

• Unstable diabetes with blood glucose > 2 g/L
• Renal insufficiency with GFR ≤ 45 mL/min/ 1.73 m².

Other

• 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
• Impossibility to hold lying motionless at least 1 hour, or known claustrophobia
• Pregnant, likely to be pregnant or breastfeeding woman

• Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
• Patient has valid health insurance
• 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
• 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
  • Metastatic status documented by [18F]FDG PET/CT ± conventional imaging with at least one evaluable metastasis in [18F]FDG PET/CT according to PERCIST
• ECOG performance status < 2.
• Negative serum/urine pregnancy test prior to [68Ga]Ga-PentixaFor administration.
• Consent to use a contraception method for at least 3 months after each administration of [68Ga]Ga-PentixaFor.
• Adequate Organ function confirmed by laboratory tests results allowing for safe administration of [68Ga]Ga-PTF
• Life expectancy at least 3 months.