Using Pyrotinib to Reduce Recurrence Risk in Early Stage HER2-positive Breast Cancer

Evaluating the Efficacy and Safety of Pyrotinib After Adjuvant Anti-HRE2 Therapy in Women With High-risk in Early or Locally Advanced Stage Breast Cancer

This study is testing if the drug pyrotinib can help reduce the chances of breast cancer coming back in women with early stage HER2-positive breast cancer who haven't fully responded to previous treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: trastuzumab, pertuzumab, neratinib, pyrotinib
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05834764 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of pyrotinib in reducing the risk of recurrence in women with high-risk early stage HER2-positive breast cancer who have previously been treated with trastuzumab and pertuzumab or T-DM1. The study aims to build on previous findings that suggest extending anti-HER2 therapy can improve disease-free survival. Participants will be closely monitored to assess the impact of pyrotinib on their condition. The trial is designed for patients who have not achieved a pathologic complete response after neoadjuvant therapy.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 75 with early or locally advanced HER2-positive breast cancer who have undergone prior treatment with trastuzumab and pertuzumab or T-DM1.

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 lower the chances of cancer recurrence for patients with high-risk HER2-positive breast cancer.

How similar studies have performed: Previous studies have shown promise in extending anti-HER2 therapy, but this specific approach with pyrotinib is novel and untested.

Eligibility criteria

Inclusion Criteria:

1. Subjects voluntarily participate in this study and sign the informed consent form；
2. Female or male patients, aged ≥ 18 years, and ≤75 years;
3. ECOG PS score: 0-1;
4. Patients with HER2+ early or locally advanced breast cancer confirmed by histopathology: HER2-positive is defined by standard of 3+ by immunohistochemical staining (IHC), or 2+ by immunohistochemical staining (IHC) but positive by in situ hybridization (ISH).
5. Stage II through IIIC HER-2 positive breast cancer with node positive disease after surgery.
6. Been treated for early breast cancer with standard of care duration of trastuzumab combined with pertuzumab or T-DM1.
7. Could have been treated neoadjuvantly but have not reached pathologic complete response.

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
6. History of gastrointestinal disease with diarrhea as the major symptom.

Where this trial is running

Nanjing, Jiangsu

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

Study contacts

• Principal investigator: Xiaoan Liu, Professor — Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
• Study coordinator: Xiaoan Liu, Professor

Conditions HER2-positive Breast Cancer