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

NCT ID: NCT07057427

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 812 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-24
• Study Completion Date: 2029-06-30

Brief Summary

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nab-PHP group

Nab-paclitaxel(on days 1 and 8 of a 21-day cycle) + trastuzumab+ patuzumab (every 3 weeks)

Group Type: EXPERIMENTAL

Nab paclitaxel

Intervention Type: DRUG

Nab-paclitaxel (on days 1 and 8 of a 21-day cycle)

Trastuzumab + Pertuzumab

Intervention Type: DRUG

Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and pertuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks.

TCbHP

Docetaxel + carboplatin + trastuzumab + patuzumab (every 3 weeks)

Group Type: ACTIVE_COMPARATOR

Docetaxel and Carboplatin

Intervention Type: DRUG

Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1)

Trastuzumab + Pertuzumab

Intervention Type: DRUG

Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and pertuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks.

Interventions

Nab paclitaxel

Nab-paclitaxel (on days 1 and 8 of a 21-day cycle)

Intervention Type: DRUG

Docetaxel and Carboplatin

Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1)

Intervention Type: DRUG

Trastuzumab + Pertuzumab

Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and pertuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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):

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 × upper limit of normal (ULN)

5. Serum creatinine < 1.5 × ULN

6. 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.

Exclusion Criteria

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:

1. History of congestive heart failure or systolic dysfunction (LVEF < 50%)

2. 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])

3. Angina pectoris requiring anti-anginal medication

4. Clinically significant valvular heart disease

5. Electrocardiogram (ECG) evidence of transmural myocardial infarction

6. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zhenzhen Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henan cancer hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhenzhen Liu, PHD

Role: CONTACT

zlyyliuzhenzhen0800@zzu.edu.cn

13603862755

Facility Contacts

Zhenzhen Liu, PHD

Role: primary

zlyyliuzhenzhen0800@zzu.edu.cn

13603862755

Other Identifiers

HELEN-006Lite

Identifier Type: -

Identifier Source: org_study_id