Trials / Completed
CompletedNCT00878709
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,840 (actual)
- Sponsor
- Puma Biotechnology, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate whether neratinib 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 | neratinib | |
| OTHER | placebo |
Timeline
- Start date
- 2009-07-09
- Primary completion
- 2014-08-21
- Completion
- 2019-10-04
- First posted
- 2009-04-09
- Last updated
- 2021-06-11
- Results posted
- 2017-10-09
Locations
494 sites across 40 countries: United States, Australia, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, North Macedonia, Peru, Poland, Romania, Serbia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, The Bahamas, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00878709. Inclusion in this directory is not an endorsement.