OncoMatch/Clinical Trials/NCT05430399
Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer
Is NCT05430399 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including utidelone and docetaxel for breast neoplasms.
Treatment: utidelone · docetaxel — It is a phase III trial to explore the efficacy and safety of utidelone versus docetaxel in HER2-negative locally advanced or metastatic breast cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
The primary tumor and metastases (if re-biopsy was performed) were both HER2-negative
Disease stage
Required: Stage III, IV
Metastatic disease required
locally advanced or metastatic, histologically or cytologically documented breast cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: taxane — early breast cancer (neoadjuvant or adjuvant)
Previous chemotherapy with taxane for early breast cancer (eBC; neoadjuvant or adjuvant setting) is permitted if completed ≥12 months before randomization
Cannot have received: chemotherapy
Exception: adjuvant/neoadjuvant taxane completed ≥12 months before randomization
No previous chemotherapy for advanced breast cancer
Cannot have received: anti-tumor therapy
Patients who have received anti-tumor therapy within 4 weeks prior to the start of study treatment, including chemotherapy, radical radiotherapy, biological therapy, immunotherapy or anti-tumor Chinese medicine therapy
Lab requirements
Blood counts
adequate hematological function
Kidney function
adequate renal function
Liver function
adequate hepatic function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05430399 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required (metastatic disease required).
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