Comparing two chemotherapy regimens for early HER2-positive breast cancer

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 study tests whether a new chemotherapy treatment using nab-paclitaxel is better than the standard treatment for women with early HER2-positive breast cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 688 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: chemotherapy, trastuzumab, pertuzumab
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT04547907 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy of nab-paclitaxel monotherapy versus the standard regimen of docetaxel plus carboplatin, both combined with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer. Patients aged 18-70 with confirmed HER2-positive invasive breast cancer will be randomly assigned to receive either the experimental nab-PHP regimen or the control TCbHP regimen. The study will assess outcomes such as pathological complete response (pCR), event-free survival (EFS), invasive disease-free survival (iDFS), and safety profiles. Surgical intervention will follow the completion of chemotherapy for pathological evaluation of the excised specimens.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-70 with clinically measurable HER2-positive invasive breast cancer.

Not a fit: Patients with contraindications to chemotherapy or those with non-invasive breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective neoadjuvant treatment option for patients with HER2-positive early breast cancer.

How similar studies have performed: Other studies have shown promising results with similar chemotherapy regimens in treating HER2-positive breast cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age: 18-70 years;
2. Clinical T2-T4d, or T1c with axillary lymph node positivity;
3. Histopathologically confirmed HER2-positive invasive breast cancer; Note: HER2 positivity was determined by immunohistochemical (IHC) staining of 3+ or, if IHC 2+, by HER2 gene amplification as demonstrated by fluorescence in situ hybridization (FISH) assay；
4. Have clinically measurable lesions: Measurable lesions shown on ultrasound, mammography, or MR (optional) within 1 month before randomization;
5. No chemotherapy contraindications detected by organ and bone marrow function tests within 1 month before chemotherapy:

   1. Neutrophil count absolute value ≧2.0×109/L;
   2. Hemoglobin ≧ 100g/L;
   3. Platelet count ≧100×109/L;
   4. Total bilirubin \<1.5 ULN (upper limit of normal);
   5. Creatinine \< 1.5×ULN
   6. AST/ALT \< 1.5×ULN;
6. Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 55%);
7. Reproductive age women, negative serum pregnancy test within 14 days before randomization;
8. ECOG score 0 or 1;
9. Signature of informed consent.

Exclusion Criteria:

1. Stage IV (metastatic) breast cancer;
2. Bilateral breast cancer;
3. Patients who have received chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this disease;
4. Patients with a second primary malignancy, except for adequately treated skin cancer;
5. Major non-breast cancer-related surgical procedures within the past 4 weeks before enrollment, or patients have not fully recovered from such surgical procedures;
6. Severe heart disease or conditions that do not allow participation in the study, including but not limited to the following:

   1. History of heart failure or systolic dysfunction (LVEF \< 50%);
   2. High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \> 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-grade atrioventricular conduction blocks (i.e., Mobitz II second-degree atrioventricular block or third-degree atrioventricular block);
   3. Angina pectoris requiring anti-anginal drug therapy;
   4. Clinically significant valvular heart disease;
   5. ECG showing a transmural myocardial infarction;
   6. Uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg);
7. Due to severe and uncontrolled other medical conditions, the investigator considers chemotherapy to be contraindicated;
8. 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

• Principal investigator: Zhenzhen Liu — Study Principal Investigator Henan Cancer Hospital
• Study coordinator: Zhenzhen Liu

Conditions Breast Cancer,HER2-positive