Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Location status: Recruiting
Location contact
yuan peng, Dr
CONTACT
NCT Number: NCT06693024
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.
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Observational
Beijing, Beijing Municipality, 100044, China
Location status: Recruiting
yuan peng, Dr
CONTACT
Investigators retrospectively recuited patients with early HER2 positive breast cancer treated in Peking University People's Hospital center from January 1, 2019 to November 31, 2024, and prospectively recruit same patients from December 1, 2024 to December 31, 2028. To compare the efficacy and safety of sequential use of neratinib.
Inclusion criteria
Exclusion criteria
patients recieved Neratinib for 1 year or not.
Primary end point: 5-year invasive dieased free survival
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
neratinib 240mg qd for 1 year
Time frame: 5 years
The time from study enrollment to the first occurrence of the following events defined as failure: local recurrence of ipsilateral invasive breast cancer, contralateral invasive breast cancer, distant recurrence or death from any cause.
Time frame: 5 years
The time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause.
Time frame: 5 years
Time from study enrollment to distant recurrence and metastasis
Time frame: 5 years
Time from study enrollment to death due to breast cancer
Time frame: 5 years
Time from study enrollment to death from any cause
Contact information is provided by the study sponsor or research team.
Shu Wang
Other
A Cohort Study of Adjuvant Therapy With Naratinib in HER2 Positive Early Breast Cancer
Acronym: NeraHER2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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