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Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer (ExteNET)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00878709
First received: April 8, 2009
Last updated: May 7, 2012
Last verified: May 2012
History of Changes

April 8, 2009
May 7, 2012
July 2009
October 2012   (final data collection date for primary outcome measure)
disease free survival (DFS) [ Time Frame: Two years ] [ Designated as safety issue: No ]
disease free survival [ Time Frame: five years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00878709 on ClinicalTrials.gov Archive Site
  • Time to Distant Recurrence (TTDR) [ Time Frame: Two Years ] [ Designated as safety issue: No ]
    The time between randomization and the date of the first distant recurrence, or death from breast cancer
  • Disease free survival including ductal carcinoma in situ (DFS-DCIS) [ Time Frame: Two years ] [ Designated as safety issue: No ]
    The time from randomization to the first occurrence of any DFS event or DCIS
  • Distant disease free survival (DDFS) [ Time Frame: Two years ] [ Designated as safety issue: No ]
    The time from randomization to the first distant recurrence or death from any cause.
  • Incidence of central nervous system recurrence [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Short and long term safety of neratinib [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
Common Terminology for Adverse Events (CTCAE) version 3 [ Time Frame: duration of subject's participation on active portion of study ] [ Designated as safety issue: Yes ]
 
 
 
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

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.
 
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Breast Cancer
  • Drug: neratinib
    240 mg orally daily for 1 year
    Other Name: HKI-272
  • Other: placebo
    orally daily for 1 year
  • Experimental: 1
    Intervention: Drug: neratinib
  • Placebo Comparator: 2
    Intervention: Other: placebo
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2842
October 2013
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
  • Been treated for early breast cancer with standard of care duration of trastuzumab.
  • Could have been treated neoadjuvantly but have not reached pCR.

Exclusion Criteria:

  • Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
  • History of heart disease.
  • QTc interval >0.45 seconds
  • History of gastrointestinal disease with diarrhea as the major symptom.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Bahamas,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Colombia,   Croatia,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Lithuania,   Macedonia, The Former Yugoslav Republic of,   Malaysia,   Malta,   Mexico,   Netherlands,   New Zealand,   Peru,   Poland,   Romania,   Serbia,   Singapore,   Slovakia,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom
 
NCT00878709
3144A2-3004, B1891004
Yes
Puma Biotechnology, Inc.
Puma Biotechnology, Inc.
 
Study Director: Puma Biotechnology
Puma Biotechnology, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP