Comparing nab‑paclitaxel versus docetaxel plus carboplatin with trastuzumab and pertuzumab for HER2‑positive early breast cancer neoadjuvant treatment

Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer, A Multicenter, Randomized, Phase III Clinical Trial

This trial will test whether nab‑paclitaxel combined with trastuzumab and pertuzumab works as well as the standard docetaxel‑and‑carboplatin regimen with the same antibodies for people with HER2‑positive early breast cancer before surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 812 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: chemotherapy, trastuzumab, pertuzumab
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT07057427 on ClinicalTrials.gov

What this trial studies

This phase 3 randomized interventional trial compares two neoadjuvant chemotherapy backbones given with dual anti‑HER2 therapy (trastuzumab and pertuzumab) in patients with HER2‑positive early breast cancer. One arm receives nab‑paclitaxel on days 1 and 8 of a 21‑day cycle plus trastuzumab and pertuzumab, and the other receives docetaxel plus carboplatin with the same antibody combination. Eligible patients are adults 18–70 years with T2–T4d tumors or T1c tumors with positive axillary nodes, measurable disease, and adequate organ and marrow function. Tumor response and safety will be followed through preoperative assessments and definitive surgery.

Who should consider this trial

Good fit: Adults 18–70 years old with histologically confirmed HER2‑positive invasive breast cancer (T2–T4d or T1c with axillary node positivity), measurable disease, and adequate organ and bone marrow function are ideal candidates.

Not a fit: Patients with HER2‑negative disease, metastatic cancer, prior systemic therapy for this diagnosis, significant organ dysfunction, or those outside the specified tumor stages or age range are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the regimen with nab‑paclitaxel could provide an equally effective neoadjuvant option that may reduce certain toxicities or offer a more convenient chemotherapy schedule for some patients.

How similar studies have performed: Prior trials combining dual HER2 blockade with taxane‑based neoadjuvant regimens have improved pathologic complete response rates, but direct head‑to‑head data comparing nab‑paclitaxel versus docetaxel‑plus‑carboplatin in this setting are limited.

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.

Where this trial is running

Zhengzhou, Henan

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

Study contacts

• Study coordinator: Zhenzhen Liu, PHD

Conditions Breast Cancer; HER2 positive; neoadjuvant therapy; Chemotherapy de-escalation