Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: neratinib.
- Who it may be relevant to
- Registry conditions: HER2-positive Breast Cancer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Cohort Study of Adjuvant Therapy With Naratinib in HER2 Positive Early Breast Cancer
Overview
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.
Detailed description
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:
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 Peking University People's 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
patients recieved Neratinib for 1 year or not.
Primary end point: 5-year invasive dieased free survival
Interventions
- Drug neratinib
neratinib 240mg qd for 1 year
Primary outcome measures
- invasive disease free survival [Time frame: 5 years]
Secondary outcome measures (4)
- disease free survival [Time frame: 5 years]
- distant disease free survival [Time frame: 5 years]
- breast cancer specific survival [Time frame: 5 years]
- overall survival [Time frame: 5 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT06693024 · PKUPH2024Z168