Trials / Recruiting
RecruitingNCT04254263
Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
Adjuvant Trastuzumab Plus Pyrotinib for Residual Invasive HER2-positive Breast Cancer After Neoadjuvant Chemotherapy Plus Anti-HER2 Target Therapy
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 316 (estimated)
- Sponsor
- RenJi Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pyrotinib | pyrotinib 400 mg, orally once daily for one year |
Timeline
- Start date
- 2019-12-16
- Primary completion
- 2026-08-01
- Completion
- 2028-08-01
- First posted
- 2020-02-05
- Last updated
- 2025-09-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04254263. Inclusion in this directory is not an endorsement.