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

NCT07057427 | Recruiting Phase 3

• 1 other identifier: HELEN-006Lite
• Study Type: interventional
• Target: 812
• Locations: 1 country
• Sites: 1

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

Keywords

HER2 positive; neoadjuvant therapy; Chemotherapy de-escalation

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR)

  through study completion, up to 6 months

Secondary Outcomes (7)

• Event-Free Survival (EFS)

  5 years after surgery

• Invasive Disease-Free Survival (iDFS)

  5 years after surgery

• Safety-Number of adverse events and serious adverse events.

  up to 1 year

• Tolerability-Dose adjustment rate and withdrawal rate of chemotherapy drugs

  up to 1 year

• Residual Cancer Burden (RCB)

  up to 6 months

Other Outcomes (1)

• Exploratory endpoint - Differences in pCR rates between predefined subgroups and factors influencing pCR in the study population.

  through study completion, an average of 1 year

Study Arms (2)

Nab-PHP group

EXPERIMENTAL

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

Drug: Nab paclitaxel; Drug: Trastuzumab + Pertuzumab

TCbHP

ACTIVE COMPARATOR

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

Drug: Docetaxel and Carboplatin; Drug: Trastuzumab + Pertuzumab

Interventions

Nab paclitaxel DRUG

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

Nab-PHP group

Docetaxel and Carboplatin DRUG

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

TCbHP

Trastuzumab + Pertuzumab 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.

Nab-PHP group; TCbHP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan cancer hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Taxes; Docetaxel; Carboplatin; Trastuzumab; pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Zhenzhen Liu, PHD

CONTACT

13603862755; zlyyliuzhenzhen0800@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 9, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

CN (1)