Clinical Trial

Paclitaxel Oral Solution in Triple Neagtive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study

Study acronym: GBCF003
Recruiting Phase 1/2
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Summary
This is a multicenter, open-label, dose-escalation trial using a backfill Bayesian optimal interval (BF-BOIN) design to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) for paclitaxel oral solution followed by epirubicin plus cyclophosphamide therapy. Eligible triple-negative breast cancer patients are enrolled in three cohorts at oral paclitaxel dose levels 1-3 (125, 150, 175 mg/m²).
Protocol Amendment History 1 change
critical Recruitment opened 2026-08-05
Trial Details
NCT Number NCT07739485
Lead Sponsor Liu Shu
Conditions Triple -Negative Breast Cancer
Enrollment 30 participants
Start Date 2026-07-30
Primary Completion 2027-07-30 (estimated)
Study Completion 2029-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-04