GALLIUM (68GA), PENTIXAFOR for Triple-negative breast cancer

Inclusion criteria

• {"criterion_text":"-1)\tWritten informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations"}
• {"criterion_text":"-10)\tPatient has valid health insurance"}
• {"criterion_text":"-11)\tPatient 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"}
• {"criterion_text":"-2)\tFemale or male, Age ≥ 18 years at time of study entry"}
• {"criterion_text":"-3)\tPrimitive triple negative breast cancer proven histologically, defined according to the following criteria: ⇢\tEstrogen receptors <10%. ⇢\tAnd progesterone receptors <10%. ⇢\tAnd HER2 not amplified or not overexpressed"}
• {"criterion_text":"-Metastatic status documented by [18F]FDG PET/CT ± conventional imaging with at least one evaluable metastasis in [18F]FDG PET/CT according to PERCIST"}
• {"criterion_text":"-5)\tECOG performance status < 2."}
• {"criterion_text":"-6)\tNegative serum/urine pregnancy test prior to [68Ga]Ga-PentixaFor administration."}
• {"criterion_text":"-7)\tConsent to use a contraception method for at least 3 months after each administration of [68Ga]Ga-PentixaFor."}
• {"criterion_text":"-8)\tAdequate Organ function confirmed by laboratory tests results allowing for safe administration of [68Ga]Ga-PTF"}
• {"criterion_text":"-9)\tLife expectancy at least 3 months."}

Exclusion criteria

• {"criterion_text":"-1)\tHistory of another primary malignancy within the last 3 years except for basal cell carcinoma."}
• {"criterion_text":"-10)\tBody weight of less than 48 kg"}
• {"criterion_text":"-11)\tPersons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian"}
• {"criterion_text":"-12)\tDisorder precluding understanding of trial information or informed consent"}
• {"criterion_text":"-2)\tChemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first [68Ga]Ga-PTF administration"}
• {"criterion_text":"-3)\tImpossibility to hold lying motionless at least 1 hour, or known claustrophobia"}
• {"criterion_text":"-4)\tSerious 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"}
• {"criterion_text":"-5)\tMental impairment that may compromise the ability to give informed consent and comply with the requirements of the study"}
• {"criterion_text":"-6)\tPregnant, likely to be pregnant or breastfeeding woman"}
• {"criterion_text":"-7)\tUnstable diabetes with blood glucose > 2 g/L"}
• {"criterion_text":"-8)\tRenal insufficiency with GFR ≤ 45 mL/min/ 1.73 m²."}
• {"criterion_text":"-9)\tKnown hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PentixaFor and/or [18F]FDG product"}

Primary endpoints

• {"endpoint_text":"-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.","definition_or_measurement_approach":"Lesion-by-lesion analysis comparing [18F]FDG PET/CT and [68Ga]Ga-PentixaFor PET/CT at inclusion; measurement is the ratio: Number of positive or negative [68Ga]Ga-PentixaFor lesions / Number of positive or negative FDG lesions."}

Secondary endpoints

• {"endpoint_text":"-a) 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 imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT. .","definition_or_measurement_approach":"Lesion-by-lesion concordance at imaging evaluation 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT using the ratio: Number of [68Ga]Ga-PentixaFor positive/negative lesions divided by number of FDG positive/negative lesions."}
• {"endpoint_text":"-b) 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.","definition_or_measurement_approach":"Lesion-level analysis comparing [68Ga]Ga-PentixaFor PET/CT to CT at inclusion; measurement is the ratio: number of [68Ga]Ga-PentixaFor(+) lesions / number of CT-detected lesions."}
• {"endpoint_text":"-c) 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 imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT","definition_or_measurement_approach":"Lesion-level comparison of [68Ga]Ga-PentixaFor PET/CT vs CT at imaging evaluation 3 to 9 months after first PET/CT; measurement is the ratio of [68Ga]Ga-PentixaFor(+) lesions to CT lesions."}
• {"endpoint_text":"-d) Percentage of [68Ga]Ga-PentixaFor(+) metastatic tumor burden compared to total metastatic tumor burden by [18F]FDG PET/CT .","definition_or_measurement_approach":"Calculate percentage of metastatic tumor burden (whole body) positive on [68Ga]Ga-PentixaFor relative to total metastatic tumor burden determined by [18F]FDG PET/CT."}
• {"endpoint_text":"-e) Assess the correlation between the standard uptake values (SUV) of [68Ga]Ga-PentixaFor and IHC CXCR4 expression, by comparing the [68Ga]Ga-PentixaFor semi-quantitative data with the CXCR4 expression results of biopsied metastases at screening and at imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT if biopsy is performed.","definition_or_measurement_approach":"Correlation analysis between [68Ga]Ga-PentixaFor SUV values and immunohistochemistry (IHC) CXCR4 expression from biopsied metastases at screening and at imaging evaluation 3 to 9 months after first PET/CT (if biopsy performed)."}
• {"endpoint_text":"-f) The tolerance of [68Ga]Ga-PentixaFor will be checked by measuring and monitoring vital signs for 60 minutes after [68Ga]Ga-PentixaFor administration. The patient will be informed that in the event of abnormal physical signs, occurring within 48 hours after [68Ga]Ga-PentixaFor administration, he (she) must inform the investigator for registration. The CTC-NCI Common Toxicity Criteria, version 5.0 reference will be used.","definition_or_measurement_approach":"Safety/tolerability monitoring via vital signs for 60 minutes post-administration; patient-reported events within 48 hours to be reported; adverse events graded using CTCAE v5.0."}
• {"endpoint_text":"-g) Description of [68Ga]Ga-PentixaFor PET-CT data between patient inclusion time and imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT at the patient level will focus on the evolution of SUV.","definition_or_measurement_approach":"Descriptive analysis of evolution of SUV on [68Ga]Ga-PentixaFor PET-CT between inclusion and the 3-9 month imaging evaluation at patient level."}
• {"endpoint_text":"-Exploratory )Plasma FLT3-Ligand dosage will be assessed at screening and at imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT.","definition_or_measurement_approach":"Plasma FLT3-Ligand concentration measured at screening and at imaging evaluation 3 to 9 months after first PET/CT (exploratory biomarker assessment)."}

Other endpoints

• {"endpoint_text":"-Exploratory )Plasma FLT3-Ligand dosage will be assessed at screening and at imaging evaluation performed within 3 to 9 months after first [68Ga]Ga-PentixaFor PET/CT.","definition_or_measurement_approach":"Plasma FLT3-Ligand measured at screening and at the 3-9 month imaging evaluation; exploratory biomarker endpoint."}

France

Earliest CTIS Part Ii Submission Date

20-03-2025

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

398

Number Of Sites

1

Number Of Participants

12

Primary sponsor

Full Name

Institut De Cancerologie De L Ouest

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"PENTIXAPAHRM","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"SIRIC","duties_or_roles":"Source of monetary support","organisation_type":""}