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).
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 staging system (T1cN0M0 excluded).
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%.
History of prior invasive breast cancer.
Bilateral breast cancer, or inflammatory breast cancer (e.g., erythema and/or skin involvement and/or pathological evidence of tumor cells in dermal lymphatics).
Prior excisional and/or incisional biopsy of the primary tumor and/or axillary lymph nodes.
Prior systemic therapy for breast cancer.
Liu Shu
Lead sponsor
The Affiliated Hospital Of Guizhou Medical University
Sponsor institution