Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer

NCT06693024 | Recruiting

• 1 other identifier: PKUPH2024Z168
• Study Type: observational
• Target: 2,806
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HER2-positive Breast Cancer

Keywords

adjuvant therapy; neratinib

Outcome Measures

Primary Outcomes (1)

• invasive disease free survival

  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.

  5 years

Secondary Outcomes (4)

• disease free survival

  5 years

• distant disease free survival

  5 years

• breast cancer specific survival

  5 years

• overall survival

  5 years

Study Arms (2)

neratinib

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

Drug: neratinib

control group

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

Interventions

neratinib DRUG

neratinib 240mg qd for 1 year

neratinib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Early stage HER2 positive breast cancer patients received radical surgery and standard neoadjuvant/adjuvant therapy

You may qualify if:

• \) Patients with HER2 positive breast cancer who were diagnosed by core needle biopsy/operation in Peking University People's hospital;
• \) The patients were treated in our hospital and underwent radical resection with hospitalization records;
• \) Received standard anti-HER2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, T-DM1)
• \) Has signed and agreed to participate in the PKUPH breast disease cohort study.

You may not qualify if:

• \) Lack of clinical and pathological data (such as imaging data and pathological data);
• \) Patients with metastatic breast cancer or bilateral breast cancer;
• \) Failure to perform radical surgery

Sponsors & Collaborators

• Shu Wang: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor paraffin sample for each patient

MeSH Terms

Interventions

neratinib

Study Officials

• shu wang, doctor

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yuan peng, doctor

CONTACT

86+13671287670; 13671287670@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of breast center

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

CN (1)