Neoadjuvant treatment for HER2-enriched breast cancer using Pyrotinib, Trastuzumab, and Abraxane

Neoadjuvant Treatment of Pyrotinib in Combination With Trastuzumab and Abraxane in Patients With HER2-enriched Early or Locally Advanced Breast Cancer, a Single, One Arm, Multicenter II Phase Study

This study is testing a new combination of three drugs to see if it can help people with HER2-enriched breast cancer respond better to treatment before surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05659056 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a combination therapy involving Pyrotinib, Trastuzumab, and Abraxane in patients with HER2-enriched breast cancer. The study aims to enhance the pathologic complete response (pCR) rates in these patients, who are known to respond better to anti-HER2 therapies. By focusing on the genetic and molecular characteristics of breast cancer, the trial seeks to provide a more precise treatment regimen tailored to the unique needs of HER2-enriched patients. The trial is designed for early-stage or locally advanced breast cancer patients who meet specific inclusion criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are female patients aged 18 to 75 with histologically confirmed HER2-positive breast cancer who have not metastasized.

Not a fit: Patients with metastatic disease or inflammatory breast cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with HER2-enriched breast cancer by increasing the likelihood of achieving a complete response to therapy.

How similar studies have performed: Previous studies have indicated that HER2-enriched patients tend to achieve higher pCR rates with anti-HER2 therapies, suggesting that this approach may build on established findings.

Eligibility criteria

Inclusion Criteria:

1. female patients, 18 years ≤ age ≤ 75 years；
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
3. Histologically confirmed invasive breast cancer（early stage or locally advanced）
4. HER2 positive (HER2+++ by IHC or FISH+), and the HER2-enriched subtype screened by BulePrint test;
5. Primary breast cancer;
6. Known hormone receptor status.
7. The organs are functioning normally, like the liver function, the renal function， and the baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
8. Signed informed consent form (ICF)

Exclusion Criteria:

1. metastatic disease (Stage IV) or inflammatory breast cancer
2. Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
3. Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
4. A history of allergy to the drugs in this study；
5. Unable or unwilling to swallow tablets

Where this trial is running

Nanjing, Jiangsu

• JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Wenbin Zhou, Professor

Conditions: Breast Cancer, HER2-enriched, Pyrotinib, neoadjuvant therapy, pCR