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

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 observational study aims to evaluate the efficacy and safety of Pyrotinib, a tyrosine kinase inhibitor, in combination with Capecitabine for the adjuvant treatment of HER2 positive early-stage breast cancer. It will compare this combination therapy to the treatment of physician's choice in a multicenter registry-based cohort. Eligible participants include female patients aged 18 to 75 with confirmed HER2 positive breast cancer who have undergone surgery. The study will assess outcomes within 90 days post-surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female patients ≥ 18 years and ≤ 75 years old;
2. Primary invasive breast cancer confirmed by histology;
3. HER2 positive breast cancer (IHC 3+, or IHC 2+ and FISH positive); lymph node positive, except for T0; lymph node negative and tumor \>1cm, or tumor \> 0.5 cm and ≤ 1cm, and accompanied by any of the following high-risk factors: pathological grade 3, ER/PR negative, or \< 35 years old;
4. Having received mastectomy or breast conserving surgery, and received sentinel lymph node biopsy or axillary lymph node dissection, and within 90 days from the breast surgery;
5. With known ER/PR status of breast cancer;
6. ECOG score 0-1;
7. The patient's major organ functions meet all of the following requirements for blood tests:

   1. Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L);
   2. Platelet count (PLT) ≥ 75,000/mm3 (75×109/L);
   3. Hemoglobin (Hb) ≥ 8 g/dL (80 g/L);
   4. Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min;
   5. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
   6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 times the upper limit of normal (ULN), patients with liver metastases should be ≤ 5×ULN.

9\. The participant voluntarily joins the study, signs the informed consent form, has good compliance, and cooperates with follow-ups.

Exclusion criteria:

1. Breast cancer recurs before enrollment, or local recurrence/ metastasis confirmed by radiology;
2. The subject has participated in other clinical trials within 4 weeks or 5 half-lives (whichever is longer) before enrollment;
3. The patient has previously received treatment including tyrosine kinase inhibitors targeting HER2 (e.g., lapatinib, neratinib, and pyrotinib);
4. The patient has been diagnosed with other malignancies within 5 years of enrollment, except for cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin which has been cured;
5. The patient is receiving anti-tumor therapies from other clinical trials;
6. Inability to swallow, chronic diarrhea, or intestinal obstruction, with multiple factors affecting drug administration and absorption;
7. The patient has undergone major surgical procedures unrelated to breast cancer within 4 weeks of enrollment, or has not fully recovered from such surgical procedures;
8. With known allergies to any components of the agents to be administered in this study; history of acquired or congenital immunodeficiency diseases, including HIV; history of HCV, active hepatitis B, or history of organ transplantation;
9. Pregnant and lactating patients, patients of fertility unwilling to take effective contraceptive measures throughout the trial;
10. With any heart disease including: (1) arrhythmia requiring medication or clinical attention; (2) myocardial infarction; (3) heart failure; (4) any other heart diseases that are considered unsuitable to the trial;
11. With any comorbidities that are considered to potentially endanger the patient's safety or interfere with the study, including but not restricted to resistant hypertension, severe diabetes, active infection, etc.;
12. With a history of neurological or mental disorders, including but not restricted to epilepsy or dementia;
13. The patient is using CYP3A4 inhibitors or inducers, or any other drugs that potentially prolong the QT interval;
14. Any other circumstances in which the researcher believes that the patient is not suitable to participate in this study.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xuefei Wang
• Email: 1210548954@qq.com
• Phone: 861069158720

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

• HER2DX-guided treatment for early-stage HER2-positive breast cancer

  This test tries to see if using the HER2DX diagnostic assay to guide personalized treatment can improve quality of life and outcomes for people with early-stage HER2-positive breast cancer.

  Recruiting at 29 sites Fundacio Clinic Barcelona · Graz and 28 other locations · NCT06446882

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.