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

Recruiting now · Phase 3

Conditions studied: Breast Cancer

In brief

The 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.

Key facts

Study ID

NCT07057427

Run by

Henan Cancer Hospital

People needed

812

Starts

2025-06-24

Expected to finish

2029-06-30

Last updated by the study team

2025-07-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18-70 years old.
• Clinical Tumor Stage: T2-T4d, or T1c with axillary lymph node positivity.
• Histologically confirmed HER2-positive invasive breast cancer:
• Note: HER2 positivity is defined as at least one assessment (either initial testing or central review) by the participating center's pathology department demonstrating tumor cells with immunohistochemistry (IHC) staining intensity of 3+ or confirmation by fluorescence in situ hybridization (FISH).
• Clinically measurable disease: Lesion measurable by ultrasound or MRI (optional) within 1 month prior to randomization.
• Adequate organ and bone marrow function within 1 month prior to chemotherapy initiation (no contraindications to chemotherapy):
• Absolute neutrophil count (ANC) ≥ 2.0 × 10⁹/L
• Hemoglobin ≥ 100 g/L
• Platelet count ≥ 100 × 10⁹/L
• Total bilirubin < 1.5 × upper limit of normal (ULN)
• Serum creatinine < 1.5 × ULN
• Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) < 1.5 × ULN
• Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 55% assessed by echocardiography.
• Women of childbearing potential: Negative serum pregnancy test within 14 days prior to randomization.
• Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Informed consent: Provision of signed written informed consent.

You may not qualify if…

• Stage IV (metastatic) breast cancer.
• Bilateral breast cancer.
• Prior systemic therapy or radiotherapy for the current breast cancer diagnosis, including chemotherapy, endocrine therapy, or targeted therapy.
• History of a second primary malignancy, except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.
• Major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or incomplete recovery from prior major surgery.
• Significant cardiac disease or dysfunction, including but not limited to:
• History of congestive heart failure or systolic dysfunction (LVEF < 50%)
• High-risk uncontrolled arrhythmias (e.g., atrial tachycardia, resting heart rate > 100 bpm, clinically significant ventricular arrhythmia [e.g., ventricular tachycardia], or higher-grade atrioventricular block [i.e., Mobitz II second-degree or third-degree heart block])
• Angina pectoris requiring anti-anginal medication
• Clinically significant valvular heart disease
• Electrocardiogram (ECG) evidence of transmural myocardial infarction
• Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
• Presence of any other severe, uncontrolled medical condition that, in the investigator's judgment, constitutes a contraindication to chemotherapy.
• Known history of allergy to any component of the study drugs; patients with a history of immune deficiency diseases, including HIV positivity, or patients with other acquired or congenital immune deficiency diseases, or a history of organ transplantation.

Where it is running

• Henan cancer hospital — Zhengzhou, Henan, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.