A Cohort Study of Adjuvant Therapy With Naratinib in HER2 Positive Early Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
yuan peng, doctor
13671287670@163.com
86+13671287670
Time Frame
Start Date: 2019-01-01
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 2806
Treatments
neratinib
After standard anti-HER2 neoadjuvant/adjuvant therapy, sequential targeted therapy with neratinib for 1 year
control group
After standard anti-HER2 neoadjuvant/adjuvant therapy, no sequential targeted therapy
Sponsors
Leads: Shu Wang

This content was sourced from clinicaltrials.gov

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