Paclitaxel Oral Solution in HER2-Positive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study

This is a multicenter, open-label, dose-finding 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 combined with anti-HER2 treatment. Eligible HER2-positive breast cancer patients receive 6 cycles of neoadjuvant THP regimen(paclitaxel oral solution + trastuzumab+pertuzumab) and are enrolled in three cohorts at oral paclitaxel dose levels 1-3 (125, 150, 175 mg/m²).

NCT Number	NCT07739511
Lead Sponsor	Liu Shu
Conditions	HER2 + Breast Cancer
Enrollment	30 participants
Start Date	2026-07-29
Primary Completion	2027-07-31 (estimated)
Study Completion	2029-07-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-04