Imaging Performance Assessment of 89Zi-girentuximab (89Zr-TLX250) PET in Metastatic Triple Negative Breast Cancer

NCT04758780 | Completed Phase 2 Results

• 1 other identifier: ICO-2020-25
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT tracer for the imaging of metastatic triple negative breast cancer (TNBC) patients.

Conditions

Triple Negative Breast Cancer

Keywords

carbonic anhydrase IX (CAIX); 89Zr- girentuximab; 89Zr-TLX250 PET/CT; Metastatic Triple Negative Breast Cancer (TNBC)

Outcome Measures

Primary Outcomes (7)

• Number of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT

  The number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CT is reported to assess the concordance for tumor lesion detection using 89Zr-TLX250 PET/CT and 18FDG) PET/CT

  5 days

• Number of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT

  Number of brain lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and 18FDG PET/CT. The detection performance of 89Zr-TLX250 PET/CT and 18FDG PET/CT for identifying brain lesions has been compared.

  5 days

• Number of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT

  Number of breast lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT

  5 days

• Number of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT

  Number of bone lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT

  5 days

• Number of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT

  Number of lymph nodes lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT

  5 days

• Number of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT

  Number of lung lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT

  5 days

• Number of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT

  Number of liver lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT

  5 days

Secondary Outcomes (4)

• Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT

  5 days

• Number of Patient With Concordance Between the 89Zr-TLX250 PET/CT Uptake and CAIX Histological Expression

  5 days

• Number of Participants With Adverse Events Related to 89Zr-TLX250

  30 days

• Number of Participants With Serious Adverse Events Related or Not to 89Zr-TLX250

  30 days

Study Arms (1)

89Zr-TLX250 PET/CT

EXPERIMENTAL

89Zr-TLX250 PET/CT

Drug: 89Zr-TLX250

Interventions

89Zr-TLX250 DRUG

89Zr-TLX250 PET/CT

Also known as: 89Zr-girentuximab

89Zr-TLX250 PET/CT

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 Human Epidermal Growth factor Receptor 2 (HER2) not amplified or not overexpressed.
• Breast Cancer (BC) recurrence documented by conventional imaging and/or FDG PET/CT with at least one measurable metastatic lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) and/or PET Response Criteria In Solid Tumors (PERCIST).
• Consent to use a contraception method for at least 30 days after administration of 89Zr-TLX250.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
• Life expectancy at least 6 months.
• 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.

You may not qualify if:

• History of another primary malignancy except for basal cell carcinoma within the last 5 years.
• Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or continuing adverse effects (\> grade 1) from such therapy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0).
• Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
• Exposure to murine or chimeric antibodies within the last 5 years.
• Previous administration of any radionuclide within 10 half-lives of the same.
• 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 or likely to be pregnant or nursing patient.
• Known hypersensitivity to girentuximab or desferoxamine.
• Renal insufficiency with Glomerular Filtration Rate : GFR ≤ 45 mL/min/ 1.73 m².
• 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
• Telix Pharmaceutical: collaborator
• SIRIC ILIAD: collaborator

Study Sites (1)

ICO René Gauducheau

Saint-Herblain, 44805, France

Location

Related Publications (1)

• Rousseau C, Heyman MF, Ferrer L, Rauscher A, Morel A, Rusu D, Frenel JS, Taupin M, Vilcot L, Allam N, Robert M, Campone M, Campion L, Kraeber-Bodere F. Prospective pilot study with [89Zr]Zr-girentuximab PET/CT: CA-IX imaging in metastatic triple negative breast cancer (OPALESCENCE). Eur J Nucl Med Mol Imaging. 2026 Mar;53(4):2403-2413. doi: 10.1007/s00259-025-07619-y. Epub 2025 Nov 1.

  PMID: 41174094 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Caroline ROUSSEAU
• Organization: Institut de cancérologie de l'Ouest

caroline.rousseau@ico.unicancer.fr

+33 240679900

Study Officials

• Caroline ROUSSEAU, MD

  Institut de Cancerologie de l'Ousest - ICO

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, open prospective study

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: February 17, 2021
• Study Start: September 21, 2021
• Primary Completion: March 31, 2023
• Study Completion: September 13, 2023
• Last Updated: February 5, 2026
• Results First Posted: December 30, 2025

Record last verified: 2025-09

Locations

FR (1)