Using Neratinib for Early HER2 Positive Breast Cancer Treatment
A Cohort Study of Adjuvant Therapy With Naratinib in HER2 Positive Early Breast Cancer
This study is testing if taking neratinib after standard treatments can help people with early HER2 positive breast cancer live longer without the disease coming back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2806 (estimated) |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, patuzumab, neratinib, naratinib |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06693024 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy and safety of sequential neratinib therapy in patients with early HER2 positive breast cancer. It will involve a retrospective recruitment of patients treated at Peking University People's Hospital from January 2019 to November 2024, followed by prospective recruitment until December 2028. The study will compare the outcomes of patients who received standard anti-HER2 therapies followed by neratinib against those who did not. The primary endpoint is the 5-year invasive disease-free survival rate.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with HER2 positive breast cancer who have undergone radical surgery and received standard anti-HER2 therapies.
Not a fit: Patients with metastatic breast cancer or those who have not undergone radical surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for the use of neratinib as an effective adjuvant therapy, potentially improving survival rates for patients with HER2 positive breast cancer.
How similar studies have performed: Previous studies have shown success with anti-HER2 therapies, but the specific sequential use of neratinib in this context is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\) Patients with HER2 positive breast cancer who were diagnosed by core needle biopsy/operation in Peking University People's hospital; * 2\) The patients were treated in our hospital and underwent radical resection with hospitalization records; * 3\) Received standard anti-HER2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, T-DM1) * 4\) Has signed and agreed to participate in the PKUPH breast disease cohort study. Exclusion Criteria: * 1\) Lack of clinical and pathological data (such as imaging data and pathological data); * 2\) Patients with metastatic breast cancer or bilateral breast cancer; * 3\) Failure to perform radical surgery
Where this trial is running
Beijing, Beijing Municipality
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: shu wang, doctor — Peking University People's Hospital
- Study coordinator: yuan peng, doctor
- Email: 13671287670@163.com
- Phone: 86+13671287670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.