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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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: neratinib
Other: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by Puma Biotechnology, Inc.:

Primary Outcome Measures:
  • disease free survival (DFS) [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2842
Study Start Date: July 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: neratinib
240 mg orally daily for 1 year
Other Name: HKI-272
Placebo Comparator: 2 Other: placebo
orally daily for 1 year

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878709

  Show 666 Study Locations
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
Study Director: Puma Biotechnology
  More Information

No publications provided

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00878709     History of Changes
Other Study ID Numbers: 3144A2-3004, B1891004
Study First Received: April 8, 2009
Last Updated: May 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Puma Biotechnology, Inc.:
HER-2/erbB-2 positive breast cancer
breast cancer
adjuvant therapy
neratinib
HKI-272

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013