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

Henan Cancer Hospital

Status and phase: Enrolling; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Trastuzumab + Pertuzumab; Drug: Docetaxel and Carboplatin; Drug: Nab paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT07057427

HELEN-006Lite

Details and patient eligibility

About

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.

Enrollment: 812 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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812 participants in 2 patient groups

Nab-PHP group

Experimental group

Description:

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

Treatment:

Drug: Nab paclitaxel

Drug: Trastuzumab + Pertuzumab

TCbHP

Active Comparator group

Description:

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

Treatment:

Drug: Docetaxel and Carboplatin

Drug: Trastuzumab + Pertuzumab