NCT06693024Recruiting
Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer
A Cohort Study of Adjuvant Therapy With Naratinib in HER2 Positive Early Breast Cancer
Source: ClinicalTrials.gov · Last updated 20 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and high risk to recurrence and metastasis. After the appearance of anti-HER2 targeted drugs, the prognosis and survival of these patients were greatly improved. In addition to trastuzumab and pertuzumab, the use of tyrosine kinase inhibitor (TKI) can further improve the survival. The evidence of previous adjuvant TKI anti-HER2 therapy was mainly from ExteNET study. However, due to the limitations of the times, ExteNET research is based on the background of only trastuzumab targeted therapy. Nowadays, there is no evidence that trastuzumab combined patuzumab,use of T-DM1, followed by sequential neratinib can still obtain absolute benefits. Therefore, there is no standard for the use of neratinib in current clinical practice. Investigators want to explore, in the real world, the efficacy and safety of sequential use of naratinib in adjuvant therapy.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2806 (estimated)
- First submitted
- 14 Nov 2024
- Start date
- 1 Jan 2019
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- Shu Wang
- Diseases
- Childhood cancers
- NCT number
- NCT06693024
What you commit to
- Study type: Observational
- Planned participants: 2806
- From 1 Jan 2019 to the primary completion date, 31 Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 2\) Patients with metastatic breast cancer or bilateral breast cancer;
- 3\) Failure to perform radical surgery
Other
- 1\) Lack of clinical and pathological data (such as imaging data and pathological data);
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.