Actively Recruiting
A Single-arm, Multicenter, Open-labeled Clinical Study of 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
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the combination of UTD1 and capecitabine in patients with metastatic HER2-negative breast cancer who also have brain metastases. It is a single-arm, multicenter, open-label clinical study aiming to assess how effective and safe this combined treatment is for this specific patient group. Participants receive UTD1 at a dose of 30 mgm2 daily for 5 days in each 21-day treatment cycle, along with capecitabine taken orally at 2000 mgm2 daily for 14 days per 21-day cycle. The treatment continues under close observation as part of this phase 1 and phase 2 study. During the study, patients undergo regular brain MRI scans and other laboratory tests to monitor treatment response and safety. The main measure is the central nervous system objective response rate assessed up to one year. Additional outcomes include clinical benefit rate, progression-free survival, and response rates, with careful tracking of side effects and overall health throughout the participation period.
CONDITIONS
Brief 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 lesion in the central nervous system with longest diameter 210 mm
- ECOG performance status of 0 to 2
- Untreated or previously treated brain metastases meeting specific stability and treatment toxicity criteria
- Blood routine examination within normal limits before enrollment
- White blood cell count 230 �d7 10^9 /L, neutrophil count 215 �d7 10^9/L, platelet count 2100 �d7 10^9 /L, hemoglobin 290 g/dl
- Normal liver and kidney function tests within one week before enrollment
- Total bilirubin 215 �d7 upper limit of normal
- Alanine aminotransferase (ALT) 25 �d7 ULN (up to 5 �d7 ULN for patients with liver metastasis)
- Aspartate transaminase (AST) 25 �d7 ULN (up to 5 �d7 ULN for patients with liver metastasis)
- Creatinine clearance rate 260 ml/min
- Negative pregnancy test and agreement to use effective contraception during study and 90 days after
- Life expectancy greater than 12 weeks
- Ability to participate and follow treatment and follow-up
You will not qualify if you...
- HER2 positive primary or metastatic lesions
- Other malignant cancers in past 5 years except cured basal cell carcinoma or carcinoma in situ of cervix
- Recent anti-tumor treatments within 4 weeks before study drug use
- Surgery on major organs or major trauma within 4 weeks before first study drug use
- Symptomatic peripheral neuropathy grade 2 or serious nervous system adverse reactions grade 3 or above
- Use of capecitabine within 6 months prior or no response/tolerance to capecitabine
- Brain lesions needing immediate local treatment or with increased size or edema posing risk
- Known or suspected leptomeningeal disease
- Non-malignant systemic diseases interfering with treatment or follow-up
- Allergy to study drugs or accessories
- Inability to undergo brain MRI
- Investigator judgment of unsuitability
- Conditions prohibiting corticosteroid use
Research Team
Q
Quchang Ouyang
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