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).
Inclusion 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 staging system (T1cN0M0 excluded).
HER2-positive status defined as IHC 3+ or IHC 2+ with FISH amplification.
Left ventricular ejection fraction (LVEF) ≥ 50%.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function assessed within 14 days prior to first dose of study drug, without blood transfusion or growth-factor support, meeting the following:
Voluntary participation with signed informed consent, good compliance, and willingness to attend follow-up.
Exclusion Criteria:
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The dose of paclitaxel oral solution is 125mg/m2.
The dose of paclitaxel oral solution is 150mg/m2.
The dose of paclitaxel oral solution is 175mg/m2.
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