This study is a prospective, single-center, single-arm, open-label research. It evaluates the safety and tolerability of 225Ac-TR2205 in patients with triple-negative breast cancer (TNBC), and assesses its radiation dosimetry and initial efficacy.
Voluntary participation in the study and signing of the informed consent form.
Female patients aged 18 years and above.
Patients with triple-negative breast cancer who have been diagnosed by histopathology [immune histochemistry estrogen receptor (ER) positive rate < 1% is defined as ER negative expression; progesterone receptor (PR) positive rate < 1% is defined as PR negative; human epidermal growth factor receptor 2 (HER2) expression 0-1+ or HER2 ++ but fluorescence in situ hybridization/colorimetric in situ hybridization (FISH/CISH) negative is defined as HER2 negative expression].
Patients with metastatic triple-negative breast cancer who have received at least 2 systemic treatments (at least 1 of which is for metastatic disease).
Patients who received radiotherapy (except palliative radiotherapy) or chemotherapy, immunotherapy within 3 weeks before treatment, except for bisphosphonates (which can be used for bone metastasis), are excluded.
Patients who received radionuclide therapy within 6 months before enrollment, such as strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, lutetium-177, actinium-225, or whole-body radiotherapy.
Patients who are undergoing chemotherapy, immunotherapy, biological therapy, off-label radionuclide therapy, or other investigational treatments.
Patients who have undergone major surgery within 28 days before enrollment.
Single group
225Ac-TR2205 Injection
DrugPatients will receive 225Ac-TR2205 injection administration at an interval of 8 weeks between each dose.
The incidence and severity grades of adverse events (AE), serious adverse events (SAE), and unexpected serious adverse reactions (SUSAR) were evaluated according to the CTCAE 5.0 standard.
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Xiaorong Sun
Lead sponsor
Shandong Cancer Hospital and Institute
Sponsor institution
