OncoMatch/Clinical Trials/NCT05535413
UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases
Is NCT05535413 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies UTD1 combined with capecitabine for metastatic her2 negative breast carcinoma.
Treatment: UTD1 combined with capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (negative)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: capecitabine (capecitabine)
Exception: capecitabine use within 6 months before enrollment; no response to capecitabine in the past (including progression during capecitabine treatment, or duration of clinical response after treatment < 3 months) or unable to tolerate capecitabine
Use capecitabine within 6 months before enrollment; No response to capecitabine in the past (including progression during capecitabine treatment, or duration of clinical response after treatment < 3 months) or unable to tolerate to capecitabine.
Cannot have received: anti-microtubule drugs
Exception: serious adverse reactions related to the nervous system of grade 3 or above
who have previously used anti-microtubule drugs and have serious adverse reactions related to the nervous system of grade 3 or above
Cannot have received: chemotherapy, radiotherapy, surgical treatment, targeted therapy, immunotherapy
Exception: within 4 weeks before enrollment
patients who have not received chemotherapy, radiotherapy, surgical treatment, targeted therapy and immunotherapy within 4 weeks before enrollment must have all toxicities restored to ≤ level 1 (CTCAE v5.0)
Cannot have received: anti tumor treatment, including chemotherapeutic radical radiotherapy, hormone therapy, biological therapy, immunotherapy or anti-tumor traditional Chinese medicine
Anti tumor treatment, including chemotherapeutic radical radiotherapy, hormone therapy, biological therapy Immunotherapy or anti-tumor traditional Chinese medicine
Lab requirements
Blood counts
WBC ≥ 30 × 10^9/L; ANC ≥ 15 × 10^9/L; PLT ≥ 100 × 10^9/L; Hemoglobin ≥ 90g/dl (transfusion/erythropoietin allowed)
Kidney function
Creatinine clearance rate (Ccr) ≥ 60ml/min
Liver function
Total bilirubin ≤ 15 × ULN; ALT ≤ 25 × ULN (≤ 5 × ULN with liver metastasis); AST ≤ 25 × ULN (≤ 5 × ULN with liver metastasis)
Blood routine examination was basically normal within 1 week before enrollment. WBC ≥ 30 × 10^9/L; Neutrophil counts (ANC) ≥ 15 × 10^9/L; Platelet count (PLT) ≥ 100 × 10^9/L; Hemoglobin ≥ 90g/dl. ... liver and kidney function tests were basically normal ... Total bilirubin ≤ 15 × ULN; ALT ≤ 25 × ULN (≤ 5 × ULN with liver metastasis); AST ≤ 25 × ULN (≤ 5 × ULN with liver metastasis); Creatinine clearance rate (Ccr) ≥ 60ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05535413 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior capecitabine, anti-microtubule drugs, chemotherapy, radiotherapy, surgical treatment, targeted therapy, immunotherapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages