Clinical trial Recruiting at 1 site Observational

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 typeObservational
SexAll
Enrollment2806 (estimated)
SponsorPeking University People's Hospital
Academic / other
Drugs / interventionstrastuzumab, pertuzumab, patuzumab, neratinib, naratinib
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJanuary 1, 2019
Main results expectedDecember 31, 2031
Study endsDecember 31, 2031
Registry record updatedNovember 20, 2024
Trial IDNCT06693024 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.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.