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OncoMatch/Clinical Trials/NCT07057427

Efficacy of Nab-PHP Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer

Is NCT07057427 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Nab paclitaxel and Docetaxel and Carboplatin for breast cancer.

Phase 3RecruitingHenan Cancer HospitalNCT07057427Data as of May 2026

Treatment: Nab paclitaxel · Docetaxel and Carboplatin · Trastuzumab + PertuzumabThe aim of this study is to evaluate the efficacy of nab-paclitaxel (on days 1 and 8 of a 21-day cycle) compared to the standard regimen of docetaxel plus carboplatin, both combined with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression (ihc 3+ or fish positive)

Disease stage

Required: Stage T4C, T4D, T1C WITH AXILLARY LYMPH NODE POSITIVITY (AJCC TNM)

Excluded: Stage IV

Clinical Tumor Stage: T2-T4d, or T1c with axillary lymph node positivity. Stage IV (metastatic) breast cancer [excluded].

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Prior systemic therapy or radiotherapy for the current breast cancer diagnosis, including chemotherapy, endocrine therapy, or targeted therapy

Cannot have received: radiation therapy

Prior systemic therapy or radiotherapy for the current breast cancer diagnosis, including chemotherapy, endocrine therapy, or targeted therapy

Lab requirements

Blood counts

ANC ≥ 2.0 × 10⁹/L; Hemoglobin ≥ 100 g/L; Platelet count ≥ 100 × 10⁹/L

Kidney function

Serum creatinine < 1.5 × ULN

Liver function

Total bilirubin < 1.5 × ULN; AST/ALT < 1.5 × ULN

Cardiac function

LVEF ≥ 55% assessed by echocardiography

Adequate organ and bone marrow function within 1 month prior to chemotherapy initiation (no contraindications to chemotherapy): 1. Absolute neutrophil count (ANC) ≥ 2.0 × 10⁹/L 2. Hemoglobin ≥ 100 g/L 3. Platelet count ≥ 100 × 10⁹/L 4. Total bilirubin < 1.5 × ULN 5. Serum creatinine < 1.5 × ULN 6. AST/ALT < 1.5 × ULN. Cardiac function: LVEF ≥ 55% assessed by echocardiography.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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