Trials / Unknown
UnknownNCT03980054
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
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
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,192 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pyrotinib | pyrotinib 400 mg, orally once daily for one year |
| DRUG | Placebo | placebo 400mg, orally once daily for one year |
Timeline
- Start date
- 2019-07-12
- Primary completion
- 2022-07-31
- Completion
- 2024-07-31
- First posted
- 2019-06-10
- Last updated
- 2021-05-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03980054. Inclusion in this directory is not an endorsement.