Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2806 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2031-12-31

Brief Summary

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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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Detailed Description

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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

Conditions

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HER2-positive Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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neratinib

After standard anti-HER2 neoadjuvant/adjuvant therapy, sequential targeted therapy with neratinib for 1 year

neratinib

Intervention Type DRUG

neratinib 240mg qd for 1 year

control group

After standard anti-HER2 neoadjuvant/adjuvant therapy, no sequential targeted therapy

No interventions assigned to this group

Interventions

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neratinib

neratinib 240mg qd for 1 year

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No