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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 (Jun 2026). This Phase 3 trial studies multiple treatments including Nab paclitaxel and Docetaxel and Carboplatin for breast cancer.

Phase 3RecruitingHenan Cancer HospitalNCT07057427Data as of Jun 2026Location: China

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

Treatments studied

Targeted therapy

Trastuzumab + Pertuzumab

Chemotherapy

Nab paclitaxelDocetaxel and Carboplatin

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)

Demographics

Ages ≤ 70

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.

Frequently asked questions

Is NCT07057427 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require ERBB2?

Yes, ERBB2 overexpression is a required biomarker for enrollment.

What disease stage is eligible?

Stage T4C or T4D or T1C WITH AXILLARY LYMPH NODE POSITIVITY is required.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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