Triple Negative Breast CancerPhase 2OPALESCENCENCT04758780
Imaging Performance Assessment of 89Zi-girentuximab (89Zr-TLX250) PET in Metastatic Triple Negative Breast Cancer
A Phase 2 study testing 89Zr-TLX250 in people with Triple Negative Breast Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- 89Zr-TLX250
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2021to 13 Sep 2023
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Phase II Pilot Study, Assessing Imaging Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT (Positron Emission Tomography/Computerized Tomography) in Metastatic Triple Negative Breast Cancer Patients
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.
Read the detailed description
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.
TNBC patients are known to be rapidly progressive and have a poor prognosis. This poor prognosis is due to the lack of common breast cancer targets in TNBC. As TNBC expresses CAIX, this stuy will evaluate CAIX targeting by using a radiolabeled monoclonal antibody that recognizes carbonic anhydrase IX (CAIX) : 89Zr- girentuximab otherwise known as 89Zr-TLX250. Previous and ongoing studies have demonstrated the potential application of 89Zr-TLX250 as a new PET/CT imaging tracer for the detection of renal cancer.
After establishing the TNBC targeting properties of the 89Zr-TLX250 PET/CT imaging tracer, it should be interesting to develop a new targeted therapy using TLX250- radiolabeled with a therapeutic radionuclide such as 177Lutétium.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- 89Zr-TLX250
- Keywords
- carbonic anhydrase IX (CAIX), 89Zr- girentuximab, 89Zr-TLX250 PET/CT, Metastatic Triple Negative Breast Cancer (TNBC)
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-TLX250Drug
Also called 89Zr-girentuximab
89Zr-TLX250 PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-TLX250 PET/CT | Experimental | 89Zr-TLX250 PET/CT Receives: Drug: 89Zr-TLX250 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 days
Secondary outcomes (4)
Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
Total tumor burden (whole body) detected on 89Zr-TLX250 PET/CT scan compared to that defined on 18FDG PET/CT used as the reference performed at day 3 (D3) and at day 5 (D5)
Measured: 5 days
Number of Patient With Concordance Between the 89Zr-TLX250 PET/CT Uptake and CAIX Histological Expression
Number of patients with a concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
Measured: 5 days
Number of Participants With Adverse Events Related to 89Zr-TLX250
All Adverse Events related to 89Zr-TLX250 are reported and assessed using CTCAE v5.0 scale
Measured: 30 days
Number of Participants With Serious Adverse Events Related or Not to 89Zr-TLX250
All Serious Adverse Events are collected between the 89Zr-TLX250 administration and 30 days after. They assessed using CTCAE v5.0 scale
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start21 Sep 2021
- Primary completion31 Mar 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric, open prospective study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Tarix Pharmaceuticals, SIRIC ILIAD
- Responsible party
- Sponsor
- Investigators
- Caroline ROUSSEAU, MD, Study chair, Institut de Cancerologie de l'Ousest - ICO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758780
- Sponsor's protocol ID
- ICO-2020-25
- Acronym
- OPALESCENCE
- Status last verified
- Sep 2025
- First submitted
- 14 Jan 2021
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41174094