Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positi… (NCT07095023) | Clinical Trial Compass
RecruitingNot Applicable
Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer
China112 participantsStarted 2025-08-15
Plain-language summary
The goal of this clinical trial is to evaluate the efficacy and safety of oral paclitaxel plus fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in the neoadjuvant treatment of HER2+ breast cancer patients.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
Aged 18-75 years old. Histologically confirmed HER2-positive invasive breast cancer with clinical stages T1c-4, N0-3, and M0 (excluding T1cN0M0), according to the 8th American Joint Committee on Cancer (AJCC) edition BC staging system HER2 overexpression was defined as immunohistochemistry (IHC) 3+ or 2+ with HER2 gene amplification, determined by fluorescence in situ hybridization (FISH).
Baseline left ventricular ejection fraction (LVEF) of ≥50%. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
The functional level of major organs must meet the following requirements (no blood transfusion and no use of white blood cell, red blood cell and platelet-raising drugs within 2 weeks before the first dose):
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Hemoglobin ≥ 9.0 g/dL
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* Alanine aminotransferase and aspartate aminotransferase (ALT/AST) ≤1.5×ULN
* Blood urea nitrogen and serum creatinine ≤1.5×ULN
* Creatinine clearance (Ccr) ≥50 ml/min (Cockcroft-Gault formula) Signature of informed consent
Exclusion Criteria:
* History of invasive breast cancer. Bilateral breast cancer or inflammatory breast cancer . 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 reactions or known hypersensitivity to any component of the investigational drug.…
What they're measuring
1
Total Pathological Complete Response(tpCR)
Timeframe: Approximately 6 months from first dose of study drug following surgery or early withdrawal, whichever occurred first (Surgery was performed within 6 weeks after neoadjuvant treatment)
Trial details
NCT IDNCT07095023
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University