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RECRUITING
NCT05834764
PHASE2

Pyrotinib in Women With High-risk in Early Stage Breast Cancer

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached. However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.

Official title: Evaluating the Efficacy and Safety of Pyrotinib After Adjuvant Anti-HRE2 Therapy in Women With High-risk in Early or Locally Advanced Stage Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

188

Start Date

2023-04-08

Completion Date

2028-12-31

Last Updated

2023-04-28

Healthy Volunteers

No

Interventions

DRUG

Pyrotinib

Pyrotinib after anti-HER2 therapy(Trastuzumab combined with Pertuzumab or T-DM1)

Locations (1)

JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China