NCT07739511
Paclitaxel Oral Solution in HER2-Positive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study
Recruiting · Phase 1, Phase 2 · Liu Shu · registry updated 2026-08-04
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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
- 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:
Exclusion
- 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.
- History of life-threatening hypersensitivity reaction, or known allergy to any component of the study drug.
- Participation in another drug or medical device clinical trial within 4 weeks prior to first dose, with receipt of investigational product or device.