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).

Trial Details

NCT ID
NCT07739511
Phase
PHASE1 / PHASE2
Sponsor
Liu Shu
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Paclitaxel oral solution plus Trastuzumab and Pertuzumab
Locations (sample)
  • Guiyang, Guizhou, China|26.58333,106.71667

Key Eligibility Criteria

  • Female, aged 18 to 70 years.
  • Histologically confirmed invasive breast cancer by core needle biopsy; clinical stage T1c-4, N0-3, M0 per the AJCC 8th edition breast cancer stagin…
  • HER2-positive status defined as IHC 3+ or IHC 2+ with FISH amplification.
  • Left ventricular ejection fraction (LVEF) ≥ 50%.

For full eligibility, visit ClinicalTrials.gov.

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