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A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Summary
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab. The main purpose of this study is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
Official title: A Phase III Study to Evaluate the Efficacy and Safety of Pyrotinib Versus Placebo in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
2135
Start Date
2019-07-12
Completion Date
2027-06
Last Updated
2026-08-17
Healthy Volunteers
No
Conditions
Interventions
Pyrotinib
pyrotinib 400 mg, orally once daily for one year
Placebo
placebo 400mg, orally once daily for one year
Locations (1)
Fudan University Cancer Hospital
Shanghai, China