Actively Recruiting
UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases
Led by Hunan Cancer Hospital · Updated on 2025-04-25
30
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, multicenter, open-labeled clinical study of UTD1 combined with Capecitabine in metastatic HER2-negative breast cancaner patients with brain metastases. This study aims to evaluate the efficacy and safety of UDT1 combined with capecitabine in metastatic HER2-negative breast cancer patients with brain metastases.
CONDITIONS
Official Title
UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 70 years
- Histologically confirmed HER2 negative recurrent and metastatic breast cancer
- At least one measurable brain lesion with longest diameter ≥ 10 mm
- ECOG performance status score of 0 to 2
- Brain metastases untreated or previously treated without progression or need for immediate local treatment
- All prior central nervous system treatment toxicities resolved to grade 1 or less (except hair loss)
- Normal blood routine within 1 week before enrollment
- White blood cell count ≥ 30 × 10^9/L
- Neutrophil count ≥ 15 × 10^9/L
- Platelet count ≥ 100 × 10^9/L
- Hemoglobin ≥ 90 g/dl (with possible transfusion or erythropoietin treatment)
- Normal liver and kidney function within 1 week before enrollment
- Total bilirubin ≤ 1.5 × upper limit of normal
- ALT and AST ≤ 2.5 × upper limit of normal (≤ 5 × ULN if liver metastasis present)
- Creatinine clearance rate ≥ 60 ml/min
- Negative pregnancy test and agreement to use effective contraception during study and 90 days after last dose
- Life expectancy greater than 12 weeks
- Ability to participate in and follow treatment and follow-up
You will not qualify if you...
- HER2 positive primary or metastatic lesions
- Other malignant cancers in the past 5 years except cured basal cell carcinoma or cervical carcinoma in situ
- Recent anti-tumor treatment including chemotherapy, radiotherapy, hormone therapy, biological therapy, immunotherapy, or traditional Chinese medicine
- Major surgery or significant trauma within 4 weeks before first study drug use or planned elective surgery during trial
- Symptomatic peripheral neuropathy grade ≥ 2 or serious nervous system adverse reactions from anti-microtubule drugs
- Capecitabine use within 6 months before enrollment or no response to capecitabine previously
- Brain lesions requiring immediate local treatment or causing risk such as brainstem lesions
- Known or suspected leptomeningeal disease
- Serious non-malignant systemic diseases interfering with treatment or follow-up
- Known or suspected allergy to study drugs or accessories
- Inability to perform brain MRI
- Investigator judgment deeming participation inappropriate
- Situations where corticosteroids are prohibited
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Quchang Ouyang
Changsha, China, 410000
Actively Recruiting
Research Team
Q
Quchang Ouyang
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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