Actively Recruiting
A Prospective, Open-label, Single-arm, Exploratory Clinical Trial to Evaluate the Safety and Tolerability of 225Ac-TR2205 Injection in Patients With Triple-negative Breast Cancer.
Led by Xiaorong Sun · Updated on 2026-01-14
15
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective, Open-label, Single-arm, Exploratory Clinical Trial to Evaluate the Safety and Tolerability of 225Ac-TR2205 Injection in Patients With Triple-negative Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Female patients aged 18 years and older
- Diagnosed with triple-negative breast cancer by histopathology
- Have metastatic triple-negative breast cancer with at least two prior systemic treatments, including one for metastatic disease
- Have at least one measurable tumor lesion according to RECIST 1.1
- ECOG performance status of 0 or 1
- Hematological toxicity from prior treatments recovered to grade 2 or less, and non-hematological toxicity to grade 1 or less (except hair loss)
- For those with reproductive potential, negative urine pregnancy test within 7 days before first dose and agree to effective contraception during treatment and for 6 months after last dose
You will not qualify if you...
- Received radiotherapy (except palliative) or chemotherapy, immunotherapy within 3 weeks before treatment, except bisphosphonates
- Received radionuclide therapy within 6 months before enrollment
- Currently undergoing chemotherapy, immunotherapy, biological therapy, off-label radionuclide therapy, or other experimental treatments
- Underwent major surgery within 28 days before enrollment
- Life expectancy estimated to be less than 3 months
- Bone scans showing super bone imaging with uniform high uptake and low urinary system visibility
- Symptomatic spinal cord compression or signs suggesting impending spinal cord compression
- Uncontrollable central nervous system metastases requiring glucocorticoids or mannitol treatment
- History of other cancers unless treated and disease-free for over 3 years, or treated non-melanoma skin or superficial bladder cancer
- Any condition interfering with study goals or inability to cooperate with imaging, treatment, or procedures as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Actively Recruiting
Research Team
X
Xiaorong Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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