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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: liuxiaoan@126.com
• Phone: 025-68308162

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• Pyrotinib plus trastuzumab and chemotherapy for HER2-positive early breast cancer

  This study tests a treatment combination of Pyrotinib, Trastuzumab and chemo given before surgery to see if it can improve responses in HER2-positive breast cancer patients who have not yet been treated.

  Recruiting Phase 2 Hebei Medical University Fourth Hospital · Shijiazhuang, Hebei · NCT07635342

• Evaluating an intelligent management system for medication adherence in breast cancer treatment

  This study is testing a new patient management system to see if it helps women with HER2-positive breast cancer stick to their medication better than usual methods while they receive pyrotinib treatment.

  Recruiting Phase 2/3 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT06958627

• Combining chemotherapy with pyrotinib and trastuzumab for HER2-positive breast cancer

  This study is testing whether combining chemotherapy with two targeted drugs, pyrotinib and trastuzumab, can help people with HER2-positive breast cancer respond better to treatment before surgery.

  Recruiting Phase 2 First Affiliated Hospital of Zhejiang University · Hangzhou · NCT06832904

• Using pyrotinib and trastuzumab for maintenance therapy in HER2-positive breast cancer

  This study is testing if using the drugs pyrotinib and trastuzumab together can help people with advanced HER2-positive breast cancer stay healthier and prevent brain tumors after their initial treatment.

  Recruiting Fujian Medical University Union Hospital · Fuzhou, Fujian · NCT06754059

• Combining Pyrotinib and Capecitabine for HER2 Positive Early-stage Breast Cancer Treatment

  This study is testing if combining two drugs, Pyrotinib and Capecitabine, can help women with early-stage HER2 positive breast cancer after surgery feel better compared to other treatments their doctors choose.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT06035016

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.