Metastatic Breast CancerEXIGENCENCT06962163
Assessement of Potential Interest of [68Ga]Ga-PentixaFor PET/CT in Metastatic Triple Negative Breast Cancer Patients
A study testing [68Ga]Ga-PentixaFor PET/CT in people with Metastatic Breast Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
Triple-negative breast cancer (TNBC) is a particularly aggressive type of breast cancer that is difficult to treat. Unlike other forms of breast cancer, TNBC tends to relapse earlier and spread more quickly to other parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- [68Ga]Ga-PentixaFor PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2025to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 HER2 not amplified or not overexpressed.
Show all 17Show fewer
- 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.
- ECOG performance status < 2.
- Negative serum/urine pregnancy test prior to [68Ga]Ga-PentixaFor administration for female patient of childbearing potential*.
- 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).
- 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).
- 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.
- 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.
- 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).
Who cannot join
- History of another primary malignancy within the last 3 years before study entry except for basal cell carcinoma.
- 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, likely to be pregnant or breastfeeding woman.
- Blood glucose > 12mmol/L.
Show all 11Show fewer
- Renal insufficiency with GFR ≤ 45 mL/min/ 1.73 m².
- Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PentixaFor and/or [18F]FDG product.
- 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.
- Disorder precluding understanding of trial information or informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut de cancerologie de l'Ouest
Saint-Herblain, 44805
Caroline ROUSSEAU, MD, PhD, +33240679931, caroline.rousseau@ico.unicancer.fr
About this study
Official title: Prospective Phase 0 Pilot Study, Assessing Potential Interest of [68Ga]Ga-PentixaFor PET/CT in Metastatic Triple Negative Breast Cancer Patients
Triple-negative breast cancer (TNBC) is a particularly aggressive type of breast cancer that is difficult to treat. Unlike other forms of breast cancer, TNBC tends to relapse earlier and spread more quickly to other parts of the body. Unfortunately, patients with TNBC have a lower survival rate, often less than five years after diagnosis. This highlights the urgent need for better treatments for TNBC.
One of the main challenges in treating TNBC is that it lacks certain receptors that other breast cancers have. These receptors are usually targeted by specific therapies, making TNBC harder to treat with targeted approaches.
Read more
Currently, a type of imaging called [18F]FDG PET/CT is the most accurate method for detecting breast cancer and its spread. However, with the rise of personalized medicine, there is a growing interest in molecular targeted approaches. These methods aim to provide highly specific diagnostics and treatments based on the unique characteristics of each patient's cancer.
One promising target for these new approaches is a receptor called CXCR4. CXCR4 is found on the surface of many cells and is involved in various processes in the body. It is often overexpressed in different types of cancer, including breast cancer. Research has shown that CXCR4 levels are higher in metastatic sites (where cancer has spread) compared to primary tumors. CXCR4 is not only present in cancer cells but also in immune cells within the tumor environment.
In invasive breast cancer, CXCR4 plays a crucial role in tumor migration, invasiveness, metastasis, and proliferation. A clinical study evaluated 18 breast cancer patients using a new imaging method called [68Ga]Ga-PentixaFor PET/CT or PET/MR. They found that this method showed higher uptake in breast cancer cases with poorer prognosis compared to the traditional [18F]FDG PET/CT. Higher CXCR4 expression is particularly seen in TNBC compared to other breast cancer subtypes.
The goal of the study is to assess how [68Ga]Ga-PentixaFor is distributed in the body using PET/CT imaging. This will help demonstrate the potential of CXCR4 as a promising target for new treatments. If successful, [68Ga]Ga-PentixaFor PET/CT could become a valuable tool for identifying patients who might benefit from treatments using [177Lu]/[90Y] PentixaTher.
Read the detailed description
Triple-negative breast cancer (TNBC) is the most aggressive and hard-to-treat form of breast cancer. TNBC has a higher propensity for earlier relapse and an increased risk of metastasis than all other forms of breast cancer. TNBC patients have a low survival rate (<5 years). This clearly shows an urgent unmet medical need for TNBC patients. The lack of receptors makes it challenging to develop more effective targeted therapy to treat TNBC.
Currently, [18F]FDG PET/CT offer highest diagnostic accuracy in the detection of breast cancer and distant metastases. With the increasing role of personalized medicine, however, the desire for molecular targeted approaches emerged, enabling high-specificity diagnostics and molecular targeted therapies with the appropriate molecular key target.
CXCR4 is a 7-transmembrane G-coupled receptor belonging to the chemokine receptor family and is expressed by a variety of cells during development and thereafter. CXCR4 has been found to be overexpressed by various human cancers including breast cancer. The level of CXCR4 expression was shown to be higher in metastatic sites as compared to the primary tumours, and changes in CXCR4 signalling have been shown to significantly alter metastatic burden in animal models. CXCR4 is not only expressed by cancer cells themselves, but also by tumour-infiltrating immune cells. Within the tumour microenvironment, the major CXCR4-expressing cells are B-lymphocytes and plasmacytoid dendritic cells, both potentially contributing to an immunosuppressive site permissive for tumour progression.
CXCR4 is frequently overexpressed in invasive breast cancer and has an important role in tumour migration, invasiveness, metastasis, and proliferation (2).
Vag et al. evaluated 18 patients with breast cancer who underwent [68Ga]Ga-PentixaFor PET/CT or PET/MR (6). It was noted that a higher SUVmax of [18F]FDG was observed in all cases, compared with [68Ga]Ga-PentixaFor. It was also noted that the uptake seen in breast cancer is associated with a poorer prognosis. Higher CXCR4 expression is seen in triple-negative breast cancer compared to the luminal subtypes. [68Ga]Ga-PentixaFor PET/CT may have a role in prognostication of breast cancer.
The purpose of this trial is to assess the biodistribution of [68Ga]Ga-PentixaFor using PET/CT imaging, thus allowing us to demonstrate the potential of CXCR4 as a promising molecular target.
After establishing the targeting properties of [68Ga]Ga-PentixaFor PET/CT in TNBC, it could act as an effective companion imaging diagnostic and therefore a useful tool for identification of patients potentially benefiting from treatment using the theragnostic equivalent [177Lu]/[90Y] PentixaTher.
- Conditions
- Metastatic Breast Cancer
- Being tested
- [68Ga]Ga-PentixaFor PET/CT
- Keywords
- Metastatic Breast Cancer, Triple negative breast cancer, [68Ga]Ga-PentixaFor PET/CT, [18F]FDG PET/CT, CXCR4
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-PentixaFor PET/CTDiagnostic test
[68Ga]Ga-PentixaFor PET-CT is performed after patient inclusion. The patient is treated as per standard of care until disease progression. Then another [68Ga]Ga-PentixaFor PET-CT is performed.
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-PentixaFor | Experimental | 2 [68Ga]Ga-PentixaFor PET-CT are performed after patient inclusion and at disease progression. Receives: Diagnostic Test: [68Ga]Ga-PentixaFor PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and [18F]FDG PET/CT based on a lesion-by-lesion basis analysis performed at patient inclusion
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
Measured: 1 day
Secondary outcomes (6)
To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and [18F]FDG PET/CT based on a lesion-by-lesion basis analysis performed at disease progression
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 disease progression
Measured: 36 months
To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and conventional imaging CT scan based on a lesion-by-lesion basis analysis performed at patient inclusion
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
Measured: 1 day
To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and conventional imaging: CT scan based on a lesion-by-lesion basis analysis performed at disease progression
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 disease progression
Measured: 36 months
To determine the percentage of total tumour burden (whole body) detected on [68Ga]Ga-PentixaFor PET/CT compared to that defined on [18F]FDG PET/CT (considered as reference).
Percentage of [68Ga]Ga-PentixaFor(+) metastatic tumour burden compared to total metastatic tumour burden by [18F]FDG PET/CT
Measured: 36 months
To assess the correlation between the standard uptake values (SUV) of [68Ga]Ga-PentixaFor and CXCR4 expression by IHC assessment on primitive and/or metastatic tumour samples at screening and at disease progression if a biopsy is performed
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 disease progression if biopsy is performed
Measured: 36 months
To assess the safety and tolerance of [68Ga]Ga-PentixaFor
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
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start5 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- \[68Ga\]Ga-PentixaFor PET-CT
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CAROLINE ROUSSEAU, MD, PhD, Principal investigator, Institut de Cancérologie de l'Ouest (ICO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962163
- Sponsor's protocol ID
- ICO-2023-17
- Acronym
- EXIGENCE
- Status last verified
- Dec 2025
- First submitted
- 29 Apr 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD data is confidential.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase 0 Pilot Study, Assessing Potential Interest of [68Ga]Ga-PentixaFor PET/CT in Metastatic Triple Negative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06962163
- Acronym / sponsor ID
- EXIGENCE / ICO-2023-17
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, Triple negative breast cancer, [68Ga]Ga-PentixaFor PET/CT, [18F]FDG PET/CT, CXCR4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Triple-negative breast cancer (TNBC) is a particularly aggressive type of breast cancer that is difficult to treat. Unlike other forms of breast cancer, TNBC tends to relapse earlier and spread more quickly to other parts of the body. Unfortunately, patients with TNBC have a lower survival rate, often less than five years after diagnosis. This highlights the urgent need for better treatments for TNBC.
One of the main challenges in treating TNBC is that it lacks certain receptors that other breast cancers have. These receptors are usually targeted by specific therapies, making TNBC harder to treat with targeted approaches.
Currently, a type of imaging called [18F]FDG PET/CT is the most accurate method for detecting breast cancer and its spread. However, with the rise of personalized medicine, there is a growing interest in molecular targeted approaches. These methods aim to provide highly specific diagnostics and treatments based on the unique characteristics of each patient's cancer.
One promising target for these new approaches is a receptor called CXCR4. CXCR4 is found on the surface of many cells and is involved in various processes in the body. It is often overexpressed in different types of cancer, including breast cancer. Research has shown that CXCR4 levels are higher in metastatic sites (where cancer has spread) compared to primary tumors. CXCR4 is not only present in cancer cells but also in immune cells within the tumor environment.
In invasive breast cancer, CXCR4 plays a crucial role in tumor migration, invasiveness, metastasis, and proliferation. A clinical study evaluated 18 breast cancer patients using a new imaging method called [68Ga]Ga-PentixaFor PET/CT or PET/MR. They found that this method showed higher uptake in breast cancer cases with poorer prognosis compared to the traditional [18F]FDG PET/CT. Higher CXCR4 expression is particularly seen in TNBC compared to other breast cancer subtypes.
The goal of the study is to assess how [68Ga]Ga-PentixaFor is distributed in the body using PET/CT imaging. This will help demonstrate the potential of CXCR4 as a promising target for new treatments. If successful, [68Ga]Ga-PentixaFor PET/CT could become a valuable tool for identifying patients who might benefit from treatments using [177Lu]/[90Y] PentixaTher.
Detailed description
Triple-negative breast cancer (TNBC) is the most aggressive and hard-to-treat form of breast cancer. TNBC has a higher propensity for earlier relapse and an increased risk of metastasis than all other forms of breast cancer. TNBC patients have a low survival rate (<5 years). This clearly shows an urgent unmet medical need for TNBC patients. The lack of receptors makes it challenging to develop more effective targeted therapy to treat TNBC.
Currently, [18F]FDG PET/CT offer highest diagnostic accuracy in the detection of breast cancer and distant metastases. With the increasing role of personalized medicine, however, the desire for molecular targeted approaches emerged, enabling high-specificity diagnostics and molecular targeted therapies with the appropriate molecular key target.
CXCR4 is a 7-transmembrane G-coupled receptor belonging to the chemokine receptor family and is expressed by a variety of cells during development and thereafter. CXCR4 has been found to be overexpressed by various human cancers including breast cancer. The level of CXCR4 expression was shown to be higher in metastatic sites as compared to the primary tumours, and changes in CXCR4 signalling have been shown to significantly alter metastatic burden in animal models. CXCR4 is not only expressed by cancer cells themselves, but also by tumour-infiltrating immune cells. Within the tumour microenvironment, the major CXCR4-expressing cells are B-lymphocytes and plasmacytoid dendritic cells, both potentially contributing to an immunosuppressive site permissive for tumour progression.
CXCR4 is frequently overexpressed in invasive breast cancer and has an important role in tumour migration, invasiveness, metastasis, and proliferation (2).
Vag et al. evaluated 18 patients with breast cancer who underwent [68Ga]Ga-PentixaFor PET/CT or PET/MR (6). It was noted that a higher SUVmax of [18F]FDG was observed in all cases, compared with [68Ga]Ga-PentixaFor. It was also noted that the uptake seen in breast cancer is associated with a poorer prognosis. Higher CXCR4 expression is seen in triple-negative breast cancer compared to the luminal subtypes. [68Ga]Ga-PentixaFor PET/CT may have a role in prognostication of breast cancer.
The purpose of this trial is to assess the biodistribution of [68Ga]Ga-PentixaFor using PET/CT imaging, thus allowing us to demonstrate the potential of CXCR4 as a promising molecular target.
After establishing the targeting properties of [68Ga]Ga-PentixaFor PET/CT in TNBC, it could act as an effective companion imaging diagnostic and therefore a useful tool for identification of patients potentially benefiting from treatment using the theragnostic equivalent [177Lu]/[90Y] PentixaTher.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- [68Ga]Ga-PentixaFor PET-CT
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-PentixaFor | Experimental | Diagnostic Test: [68Ga]Ga-PentixaFor PET/CT2 [68Ga]Ga-PentixaFor PET-CT are performed after patient inclusion and at disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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.
- ECOG performance status < 2.
Key exclusion criteria (11 listed)
- History of another primary malignancy within the last 3 years before study entry except for basal cell carcinoma.
- 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, likely to be pregnant or breastfeeding woman.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-PentixaFor PET/CT[68Ga]Ga-PentixaFor PET-CT is performed after patient inclusion. The patient is treated as per standard of care until disease progression. Then another [68Ga]Ga-PentixaFor PET-CT is performed. | Diagnostic test | [68Ga]Ga-PentixaFor |
Primary outcome
To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and [18F]FDG PET/CT based on a lesion-by-lesion basis analysis performed at patient inclusion
Time frame: 1 day
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
6 secondary outcomes
To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and [18F]FDG PET/CT based on a lesion-by-lesion basis analysis performed at disease progression
Time frame: 36 months
To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and conventional imaging CT scan based on a lesion-by-lesion basis analysis performed at patient inclusion
Time frame: 1 day
To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and conventional imaging: CT scan based on a lesion-by-lesion basis analysis performed at disease progression
Time frame: 36 months
To determine the percentage of total tumour burden (whole body) detected on [68Ga]Ga-PentixaFor PET/CT compared to that defined on [18F]FDG PET/CT (considered as reference).
Time frame: 36 months
To assess the correlation between the standard uptake values (SUV) of [68Ga]Ga-PentixaFor and CXCR4 expression by IHC assessment on primitive and/or metastatic tumour samples at screening and at disease progression if a biopsy is performed
Time frame: 36 months
To assess the safety and tolerance of [68Ga]Ga-PentixaFor
Time frame: 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No. The IPD data is confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
CAROLINE ROUSSEAU, MD, PhD principal investigator
Institut de Cancérologie de l'Ouest (ICO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [68Ga]Ga-PentixaFor PET/CT in people with Metastatic Breast Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CAROLINE ROUSSEAU, MD, PhD (+33 2 40 67 99 31, Caroline.Rousseau@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and [18F]FDG PET/CT based on a lesion-by-lesion basis analysis performed at patient inclusion (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.