Bioequivalence Study of Paclitaxel for Injection (Albumin Bound) in Subjects With Breast Cancer

StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Primary completion date changed from estimate of Jun 12, 2026 to Feb 10, 2026 Show 4 more changesShow less
    • Study completion pushed from Oct 30, 2026 to Dec 30, 2026
    • Interventions: R, 260 mg/m2, paclitaxel for injection (albumin bound). (Drug), T, 260 mg/m2, paclitaxel for injection (albumin-bound) (Drug) to R, 260 mg/m2, paclitaxel for injection (albumin bound). (Drug), T, 260 mg/m2, paclitaxel for injection (albumin-bound) (Drug)
    • Eligibility criteria expanded, about 25 words
    • Site details revised
  2. Primary completion date: Jan 10, 2026 to Jun 12, 2026
    • Study completion date: Feb 24, 2026 to Oct 30, 2026
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 5, 2025 to Mar 12, 2025
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study was a multicenter, randomized, open, single-dose, two-cycle, two-cross-dosing human bioequivalence trial designed to evaluate the bioequivalence of tested and reference preparations in breast cancer subjects.
Trial Details
NCT Number NCT06765590
Lead Sponsor Sichuan Huiyu Pharmaceutical Co., Ltd
Collaborators: The First Hospital of Jilin University, The First Affiliated Hospital of Bengbu Medical University, Chongqing Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Henan University of Science and Technology, Qianfoshan Hospital
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov