OncoMatch/Clinical Trials/NCT05535413
UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases
Is NCT05535413 recruiting? Yes, currently enrolling (May 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
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)
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.
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