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

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).

Trial Details

NCT ID
NCT07739485
Phase
PHASE1 / PHASE2
Sponsor
Liu Shu
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Epirubicin and cyclophosphamide followed by paclitaxel oral solution
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…
  • Triple-negative breast cancer (TNBC) is defined as ER \<1%, PR \<1%, and HER2-negative \[IHC 0, IHC 1+, or IHC 2+ with FISH-negative\].
  • Left ventricular ejection fraction (LVEF) ≥ 50%.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Triple Negative (TNBC) Breast Cancer Trials on Trialify →