Using Neratinib for Early HER2 Positive Breast Cancer Treatment
Official title: A Cohort Study of Adjuvant Therapy With Naratinib in HER2 Positive Early Breast Cancer
Run by Peking University People's Hospital · NCT06693024 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 2806 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, patuzumab, neratinib, naratinib |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 1, 2019 |
| Main results expected | December 31, 2031 |
| Study ends | December 31, 2031 |
| Registry record updated | November 20, 2024 |
| Trial ID | NCT06693024 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with HER2 positive breast cancer who have undergone radical surgery and received standard anti-HER2 therapies.
✕Probably not a fit
Patients with metastatic breast cancer or those who have not undergone radical surgery may not benefit from this study.
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 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.
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 gone: Previous studies have shown success with anti-HER2 therapies, but the specific sequential use of neratinib in this context is novel and untested.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
T-DXd with or without Neratinib for HER2-positive breast cancer with brain metastases
This trial tests whether adding Neratinib to Trastuzumab Deruxtecan helps treat HER2-positive breast cancer that has spread to the brain.
-
Probiotics to prevent neratinib-related diarrhea in HER2-positive breast cancer patients
This trial will test whether taking probiotics alongside standard preventive loperamide can reduce diarrhea in people with HER2-positive breast cancer who are starting neratinib compared with placebo.
-
Treatment for hormone receptor positive HER2 positive breast cancer after neoadjuvant therapy
This study is testing if combining two drugs, trastuzumab and nelatinib, can help people with hormone receptor positive HER2 positive breast cancer who still have cancer after initial treatment feel better compared to the usual combination of trastuzumab and pertuzumab.
-
Using Kadcyla and Neratinib to Treat Early HER2-positive Breast Cancer with Residual Disease
This study is testing if adding a pill called neratinib to the standard treatment can help people with early HER2-positive breast cancer who still have some cancer cells left after their initial therapy.
-
Pre-operative treatment for HER2-positive, ER-positive breast cancer
This study is testing if a new combination of treatments can help women with HER2-positive, ER-positive breast cancer before they have surgery.
-
Can we skip radiation after lumpectomy for low-risk HER2-positive breast cancer?
This study tests whether patients who had breast-conserving surgery and low-risk HER2-positive breast cancer can safely skip radiation therapy while receiving HER2-targeted treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.