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OncoMatch/Clinical Trials/NCT05430399

Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer

Is NCT05430399 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including utidelone and docetaxel for breast neoplasms.

Phase 3RecruitingSun Yat-sen UniversityNCT05430399Data as of May 2026

Treatment: utidelone · docetaxelIt is a phase III trial to explore the efficacy and safety of utidelone versus docetaxel in HER2-negative locally advanced or metastatic breast cancer.

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Extracted eligibility criteria

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)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

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