Metastatic Triple-Negative Breast CarcinomaMIMIR-mTNBCNCT05742269
Molecular PD-L1 PET/CT Imaging With 89Zr-atezolizumab in Metastatic Triple Negative Breast Cancer
An observational study of Metastatic Triple-Negative Breast Carcinoma, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The overarching purpose of this study is to improve precision medicine through more refined therapy selection for breast cancer patients who are candidates for ICI therapy (monoclonal antibodies targeting the programmed death ligand 1 (PD-L1) or programmed cell death protein 1 (PD-1)). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Triple-Negative Breast Carcinoma
- What is being tested?
- 89Zr-atezolizumab PET/CT
- Type of treatment
- Injection or infusion
- How many people
- 3 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jul 2023to 11 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with newly diagnosed irresectable or metastatic triple negative breast cancer
Who may be able to join
- Patients with metastatic triple negative breast cancer (mTNBC), defined by pathological criteria: oestrogen receptor expression <10%, progesterone receptor expression <10%, HER2 negative, on the primary tumour or a metastatic biopsy
- Measurable disease according to RECIST v1.1
- At least one metastatic lesion accessible for biopsy
- Deemed by treating physician as fit for systemic therapy according to study protocol
- ECOG performance score 0/1
- Age ≥ 18 years old
- Adequate blood tests for bone marrow, renal and hepatic functions
- Able and willing to provide written informed consent
Who cannot join
- Previous treatment with chemotherapy or targeted therapy for mTNBC. Radiation therapy and previous chemotherapy (including taxanes) in the context of curative therapy is allowed.
- Contraindications for PET/CT as defined for clinical practice
- Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix
- Patients in child-bearing age without adequate contraception. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period.
- Pregnancy or lactation
- Uncontrolled hypertension, heart-, liver-, or kidney-diseases or other medical/psychiatric disorders.
Show all 16Show fewer
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study. Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study.
- Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., no psoriatic arthritis) are permitted provided that they meet the following conditions: Rash must cover less than 10% of body surface area (BSA); Disease is well controlled at baseline and only requiring low potency topical steroids; No acute exacerbations of underlying condition within the last 12 months (not requiring PUVA [psoralen plus ultraviolet A radiation], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency or oral steroids).
- Vaccination with a live vaccine within 30 days of the first dose of study treatment
- A known history of Human Immunodeficiency Virus (HIV) infection, hepatitis B (HBsAg reactive) or hepatitis C (HCV RNA detected) infection or active tuberculosis.
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial
- Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study
- Patients with a history of allergic reaction to IV contrast requiring steroid pre-treatment should have baseline and subsequent tumor assessments performed using CT.
- The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
- Hypersensitivity to atezolizumab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular PD-L1 PET/CT Imaging With 89Zr-atezolizumab to Monitor Immune Responses in Metastatic Triple Negative Breast Cancer
The overarching purpose of this study is to improve precision medicine through more refined therapy selection for breast cancer patients who are candidates for ICI therapy (monoclonal antibodies targeting the programmed death ligand 1 (PD-L1) or programmed cell death protein 1 (PD-1)). The reference standard biomarker for ICI therapy selection is PD-L1 protein expression measured by immunohistochemistry (IHC). Several disadvantages exist with this method, the most important ones being inter- and intralesional as well as spatial heterogeneity in PD-L1 expression, as well as the need for invasive procedures to obtain material for analysis. The study hypothesis is that Positron Emission Tomography combined with Computed Tomography (PET/CT) imaging with a contemporary radiotracer (89Zr-atezolizumab), visualizing PD-L1 expression in the whole body, could be a better predictive biomarker to select which patients benefit from ICI. The use of PET/CT imaging with new radiotracers enables a non-invasive assessment of the presence of the target of treatment in the whole body and provides the possibility to combine functional information with anatomical details.
Read the detailed description
Patients with mTNBC scheduled for first line palliative systemic treatment with nab-paclitaxel and carboplatin can be included. This chemotherapy combination is used to maximize the therapeutic potential of this first line systemic treatment line, extrapolating signals from early TNBC and in the absence of signs that indicate augmented safety issues.
The investigational medical product is 89Zr-atezolizumab. The pharmaceutical preparation of the IMP consists of the precursor atezolizumab combined with zirconium-89 to form 89Zr-atezolizumab. The radiolabelling of atezolizumab will be performed at the Department of Radiopharmacy, Karolinska University Hospital, Solna. This involves an automated synthesis procedure in a Good Manufacturing Practice facility.
All patients are scheduled for treatment with nab-paclitaxel at a dose of 100 mg per square meter of body-surface area, administered intravenously, on days 1, 8, and 15, and carboplatin at a dose of Area Under the Curve (AUC) 5 on day 1 of every 28-day cycle. The patients with a PD-L1+ tumour according to IHC with the SP142 antibody (≥ 1% on immune cells) and/or 89Zr-atezolizumab tracer uptake on PET-imaging, will receive atezolizumab at a dose of 840 mg, administered intravenously, on days 1 and 15.
- Being tested
- 89Zr-atezolizumab PET/CT
- Keywords
- 89Zr-atezolizumab, PD-L1 PET, predictive biomarker
- 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-atezolizumab PET/CTDiagnostic test
All patients undergo a 89Zr-atezolizumab PET/CT. Allocation to chemotherapy + atezolizumab in case of a PD-L1 positive tumor (on IHC and/or PET)
| Study group | Role | What they receive |
|---|---|---|
| PD-L1 positive disease (on PET and/or IHC) | Nab-paclitaxel at a dose of 100 mg per square meter of body-surface area, administered intravenously, on days 1, 8, and 15, and carboplatin at a dose of Area Under the Curve (AUC) 5 on day 1 of every 28-day cycle.
The patients with a PD-L1+ tumour, according to IHC with the SP142 antibody (≥ 1% on immune cells) and/or 89Zr-atezolizumab tracer uptake on PET-imaging, will receive atezolizumab at a dose of 840 mg, administered intravenously, on days 1 and 15. Receives: Diagnostic Test: 89Zr-atezolizumab PET/CT | |
| PD-L1 negative disease (on PET and IHC) | Nab-paclitaxel at a dose of 100 mg per square meter of body-surface area, administered intravenously, on days 1, 8, and 15, and carboplatin at a dose of Area Under the Curve (AUC) 5 on day 1 of every 28-day cycle. Receives: Diagnostic Test: 89Zr-atezolizumab PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of statistical agreement (Cohen kappa coefficient) between PD-L1 status on IHC (with SP142 Ventana) and PET (with 89Zr-atezolizumab)
Level of statistical agreement by means of Cohen's kappa coefficient between PD-L1 IHC (positive defined as expression ≥1% on immune cells with SP142) and PD-L1 PET/CT (PD-L1 positivity is defined as having at least one lesion with radiotracer uptake over the background uptake).
Level of statistical agreement by means of Cohen's kappa coefficient between PD-L1 IHC (positive defined as expression ≥1% on immune cells with SP142) and PD-L1 PET/CT (PD-L1 positivity is defined as having at least one lesion with radiotracer uptake over the background uptake).
Level of statistical agreement by means of Cohen's kappa coefficient between PD-L1 IHC (positive defined as expression ≥1% on immune cells with SP142) and PD-L1 PET/CT (PD-L1 positivity is defined as having at least one lesion with radiotracer uptake over the background uptake).
Measured: baseline
Secondary outcomes (5)
Treatment outcomes - response rate
Disease response rates in three patient groups
- IHC positive and PET positive,
- IHC positive and PET negative,
- IHC negative and PET positive.
Measured: Baseline - up to one year
Treatment outcomes - progression free survival
Progression free survival in three patient groups
- IHC positive and PET positive,
- IHC positive and PET negative,
- IHC negative and PET positive.
Measured: Baseline - up to one year
Treatment-related toxicities
Treatment discontinuation rates in three patient groups
- IHC positive and PET positive,
- IHC positive and PET negative,
- IHC negative and PET positive.
Measured: Baseline - up to one year
Heterogeneity in PD-L1 status
Discordance in 89Zr-atezolizumab between different sites and within metastatic sites in the body.
Measured: Baseline
Improved staging
Percentage of 89Zr-atezolizumab uptake in sites, not previously determined on the routine radiological investigation with CT, as a measure of cancer spread determined on whole body 89Zr-atezolizumab PET/CT in and different metastases.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Jul 2023
- Primary completion1 Dec 2024
- Study completion11 Mar 2026
Why it stopped: Slow patient accrual; decreasing use of IMP.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Triple-Negative Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renske Altena, Karolinska University Hospital
- Investigators
- Renske Altena, MD PhD, Principal investigator, Karolinska InstitutetJonas Bergh, MD, Prof, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742269
- Sponsor's protocol ID
- MIMIR-mTNBC
- Acronym
- MIMIR-mTNBC
- Status last verified
- Mar 2026
- First submitted
- 17 Jan 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nijveldt JJ, Af Buren S, Tran TA, Jussing E, Nilsson JN, Kistner A, Axelsson R, Bergh J, Hartman J, Tzortzakakis A, Altena R. Feasibility of [89Zr]Zr-Atezolizumab Immuno-PET for PD-L1 Quantification in the Clinical Work-up of Metastatic Triple-Negative Breast Cancer. J Nucl Med. 2026 May 1;67(5):681-686. doi: 10.2967/jnumed.125.271459.
PubMed 41611476
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular PD-L1 PET/CT Imaging With 89Zr-atezolizumab to Monitor Immune Responses in Metastatic Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05742269
- Acronym / sponsor ID
- MIMIR-mTNBC / MIMIR-mTNBC
- Keywords
- 89Zr-atezolizumab, PD-L1 PET, predictive biomarker
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow patient accrual; decreasing use of IMP.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 23 Feb 2023 (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.
The overarching purpose of this study is to improve precision medicine through more refined therapy selection for breast cancer patients who are candidates for ICI therapy (monoclonal antibodies targeting the programmed death ligand 1 (PD-L1) or programmed cell death protein 1 (PD-1)). The reference standard biomarker for ICI therapy selection is PD-L1 protein expression measured by immunohistochemistry (IHC). Several disadvantages exist with this method, the most important ones being inter- and intralesional as well as spatial heterogeneity in PD-L1 expression, as well as the need for invasive procedures to obtain material for analysis. The study hypothesis is that Positron Emission Tomography combined with Computed Tomography (PET/CT) imaging with a contemporary radiotracer (89Zr-atezolizumab), visualizing PD-L1 expression in the whole body, could be a better predictive biomarker to select which patients benefit from ICI. The use of PET/CT imaging with new radiotracers enables a non-invasive assessment of the presence of the target of treatment in the whole body and provides the possibility to combine functional information with anatomical details.
Detailed description
Patients with mTNBC scheduled for first line palliative systemic treatment with nab-paclitaxel and carboplatin can be included. This chemotherapy combination is used to maximize the therapeutic potential of this first line systemic treatment line, extrapolating signals from early TNBC and in the absence of signs that indicate augmented safety issues.
The investigational medical product is 89Zr-atezolizumab. The pharmaceutical preparation of the IMP consists of the precursor atezolizumab combined with zirconium-89 to form 89Zr-atezolizumab. The radiolabelling of atezolizumab will be performed at the Department of Radiopharmacy, Karolinska University Hospital, Solna. This involves an automated synthesis procedure in a Good Manufacturing Practice facility.
All patients are scheduled for treatment with nab-paclitaxel at a dose of 100 mg per square meter of body-surface area, administered intravenously, on days 1, 8, and 15, and carboplatin at a dose of Area Under the Curve (AUC) 5 on day 1 of every 28-day cycle. The patients with a PD-L1+ tumour according to IHC with the SP142 antibody (≥ 1% on immune cells) and/or 89Zr-atezolizumab tracer uptake on PET-imaging, will receive atezolizumab at a dose of 840 mg, administered intravenously, on days 1 and 15.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-L1 positive disease (on PET and/or IHC) | – | Diagnostic Test: 89Zr-atezolizumab PET/CTNab-paclitaxel at a dose of 100 mg per square meter of body-surface area, administered intravenously, on days 1, 8, and 15, and carboplatin at a dose of Area Under the Curve (AUC) 5 on day 1 of every 28-day cycle. The patients with a PD-L1+ tumour, according to IHC with the SP142 antibody (≥ 1% on immune cells) and/or 89Zr-atezolizumab tracer uptake on PET-imaging, will receive atezolizumab at a dose of 840 mg, administered intravenously, on days 1 and 15. |
| PD-L1 negative disease (on PET and IHC) | – | Diagnostic Test: 89Zr-atezolizumab PET/CTNab-paclitaxel at a dose of 100 mg per square meter of body-surface area, administered intravenously, on days 1, 8, and 15, and carboplatin at a dose of Area Under the Curve (AUC) 5 on day 1 of every 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed irresectable or metastatic triple negative breast cancer
Key inclusion criteria (8 listed)
- Patients with metastatic triple negative breast cancer (mTNBC), defined by pathological criteria: oestrogen receptor expression <10%, progesterone receptor expression <10%, HER2 negative, on the primary tumour or a metastatic biopsy
- Measurable disease according to RECIST v1.1
- At least one metastatic lesion accessible for biopsy
- Deemed by treating physician as fit for systemic therapy according to study protocol
- ECOG performance score 0/1
Key exclusion criteria (16 listed)
- Previous treatment with chemotherapy or targeted therapy for mTNBC. Radiation therapy and previous chemotherapy (including taxanes) in the context of curative therapy is allowed.
- Contraindications for PET/CT as defined for clinical practice
- Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix
- Patients in child-bearing age without adequate contraception. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period.
- Pregnancy or lactation
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 |
|---|---|---|
| 89Zr-atezolizumab PET/CTAll patients undergo a 89Zr-atezolizumab PET/CT. Allocation to chemotherapy + atezolizumab in case of a PD-L1 positive tumor (on IHC and/or PET) | Diagnostic test | PD-L1 negative disease (on PET and IHC), PD-L1 positive disease (on PET and/or IHC) |
Primary outcome
Level of statistical agreement (Cohen kappa coefficient) between PD-L1 status on IHC (with SP142 Ventana) and PET (with 89Zr-atezolizumab)
Time frame: baseline
Level of statistical agreement by means of Cohen's kappa coefficient between PD-L1 IHC (positive defined as expression ≥1% on immune cells with SP142) and PD-L1 PET/CT (PD-L1 positivity is defined as having at least one lesion with radiotracer uptake over the background uptake). Level of statistical agreement by means of Cohen's kappa coefficient between PD-L1 IHC (positive defined as expression ≥1% on immune cells with SP142) and PD-L1 PET/CT (PD-L1 positivity is defined as having at least one lesion with radiotracer uptake over the background uptake). Level of statistical agreement by means of Cohen's kappa coefficient between PD-L1 IHC (positive defined as expression ≥1% on immune cells with SP142) and PD-L1 PET/CT (PD-L1 positivity is defined as having at least one lesion with radiotracer uptake over the background uptake).
5 secondary outcomes
Treatment outcomes - response rate
Time frame: Baseline - up to one year
Treatment outcomes - progression free survival
Time frame: Baseline - up to one year
Treatment-related toxicities
Time frame: Baseline - up to one year
Heterogeneity in PD-L1 status
Time frame: Baseline
Improved staging
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Slow patient accrual; decreasing use of IMP.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Derived from this study: PubMed 41611476Nijveldt JJ, Af Buren S, Tran TA, Jussing E, Nilsson JN, Kistner A, Axelsson R, Bergh J, Hartman J, Tzortzakakis A, Altena R. Feasibility of [89Zr]Zr-Atezolizumab Immuno-PET for PD-L1 Quantification in the Clinical Work-up of Metastatic Triple-Negative Breast Cancer. J Nucl Med. 2026 May 1;67(5):681-686. doi: 10.2967/jnumed.125.271459.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Renske Altena, MD PhD principal investigator
Karolinska Institutet
Jonas Bergh, MD, Prof study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Triple-Negative Breast Carcinoma, run by Karolinska University Hospital at 1 site in Sweden.
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 8 inclusion and 16 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: stopped early, as of the sponsor's last update on 13 Mar 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 Sweden. 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?
The study was stopped early (reason given: Slow patient accrual; decreasing use of IMP.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of statistical agreement (Cohen kappa coefficient) between PD-L1 status on IHC (with SP142 Ventana) and PET (with 89Zr-atezolizumab) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05742269, which also lists 1 linked publication.
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 13 Mar 2026.