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NCT Number: NCT06693024

Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

yuan peng, Dr

CONTACT

About this study

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

  • 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 Peking University People's 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.

Exclusion criteria

  • 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

patients recieved Neratinib for 1 year or not.

Primary end point: 5-year invasive dieased free survival

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neratinib

Drug

neratinib 240mg qd for 1 year

Primary outcomes

  1. invasive disease free survival

    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.

Secondary outcomes

  1. disease free survival

    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.

  2. distant disease free survival

    Time frame: 5 years

    Time from study enrollment to distant recurrence and metastasis

  3. breast cancer specific survival

    Time frame: 5 years

    Time from study enrollment to death due to breast cancer

  4. overall survival

    Time frame: 5 years

    Time from study enrollment to death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

yuan peng, doctor

CONTACT

[email protected]

86+13671287670

Sponsors and collaborators

Lead sponsor

Shu Wang

Other

Registry information

Official study title

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

Acronym: NeraHER2

Important dates

Study start
2019
Primary completion
2031
Study completion
2031
First posted
Nov 18, 2024
Registry last updated
Nov 20, 2024

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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