NCT06035016 Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer
| NCT ID | NCT06035016 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | HER2-positive Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-06-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, multicenter, registry-based cohort study to explore the efficacy and safety of Pyrotinib combined with Capecitabine for adjuvant treatment of HER2 positive early breast cancer compared with treatment of physician's choice. Pyrotinib is a small molecule tyrosine kinase inhibitor which can irreversibly inhibit HER1, HER2, and HER4.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06035016 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying HER2-positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06035016 currently recruiting?
Yes, NCT06035016 is actively recruiting participants. Contact the research team at 1210548954@qq.com for enrollment information.
Where is the NCT06035016 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06035016 clinical trial?
NCT06035016 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 300 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.