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.
Parallel
Epirubicin and cyclophosphamide followed by paclitaxel oral solution
DrugCycles 1-4: Epirubicin 90 mg/m² plus cyclophosphamide 600 mg/m² by intravenous infusion on day 1 (D1) of each cycle; one treatment cycle administered every 3 weeks. Cycles 5-8: Paclitaxel oral solution 125, 150, or 175 mg/m², given twice daily on days 1, 8, and 15 of each cycle; one cycle every 3 weeks.
Maximum Tolerated Dose(MTD)
total Pathological Complete Response(tpCR)
tpCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.
Overall Response Rate(ORR)
ORR was defined as the percentage of participants who achieved a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions) according to RECIST 1.1 by Investigator review.
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Liu Shu
Lead sponsor
The Affiliated Hospital Of Guizhou Medical University
Sponsor institution
