New Full-Body scan could replace biopsies for breast cancer immunotherapy
NCT ID NCT05742269
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a special PET/CT scan that uses a radioactive tracer to see PD-L1 (a protein targeted by immunotherapy) throughout the body. The goal was to see if this scan could better identify which patients with metastatic triple-negative breast cancer would benefit from immunotherapy, compared to the standard biopsy method. Only 3 patients were enrolled before the study was terminated, so the findings are very limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 89Zr-atezolizumab (a radioactive tracer for PET/CT scans)
- What this could lead to
- If successful, this imaging method could help doctors choose the right immunotherapy for breast cancer patients without needing repeated biopsies.
- What could go wrong
- This was a very small, early study (only 3 participants planned) and was terminated early, so results are limited. The scan may not reliably predict who benefits from treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
3 people
The number who actually took part.
- Started
-
Jul 2023
- Finished
-
Mar 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with newly diagnosed irresectable or metastatic triple negative breast cancer
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Karolinska University Hospital
Stockholm, 171 76, Sweden
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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