OncoMatch/Clinical Trials/NCT06385990
Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy
Is NCT06385990 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies UTD1 for triple negative breast neoplasms.
Treatment: UTD1 — This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug. Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative (<1% positive) (<1% positive)
ER-negative (<1% positive)
Required: PR (PGR) negative (<1% positive) (<1% positive)
PR-negative (<1% positive)
Required: HER2 (ERBB2) negative (IHC: HER2 (0), HER2 (1+), or HER2 (2+) and FISH non-amplification) (IHC: HER2 (0), HER2 (1+), or HER2 (2+) and FISH non-amplification)
HER2-negative (IHC: HER2 (0), HER2 (1+), or HER2 (2+) and FISH non-amplification)
Disease stage
Excluded: Stage METASTATIC BREAST CANCER AT DIAGNOSIS
Metastatic breast cancer at diagnosis [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: neoadjuvant chemotherapy — neoadjuvant
Patients must receive full course of neoadjuvant chemotherapy before surgery and did not achieve pathological complete response (i.e., pathologically confirmed residual lesion, maximum diameter of 1cm) or / lymph node positive (ypN+)
Must have received: anthracycline — neoadjuvant
Previous neoadjuvant chemotherapy regimen included anthracycline, taxane, or a combination of both.
Must have received: taxane — neoadjuvant
Previous neoadjuvant chemotherapy regimen included anthracycline, taxane, or a combination of both.
Cannot have received: capecitabine
The patient received either capecitabine or utiderone before surgery
Cannot have received: utidelone
The patient received either capecitabine or utiderone before surgery
Lab requirements
Blood counts
Hb > 90g/L, WBC > 3.5*10^9/L, ANC > 1.5*10^9/L, PLT > 100*10^9/L
Kidney function
serum creatinine ≤ upper limit of normal
Liver function
for patients without liver metastasis: AST, ALT, ALP <2.5x ULN, total bilirubin <1.25x ULN; for patients with liver metastasis: AST, ALT, ALP <5x ULN, total bilirubin <1.25x ULN
Cardiac function
No symptomatic congestive heart failure (NYHA II-IV), symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome or QTc > 500ms, history of uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy
Within 1 week before enrollment, the blood routine examination was basically normal...; Symptomatic congestive heart failure (New York Heart Association Grade II-IV), symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome or corrected QTc> 500ms at screening, history of uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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