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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00878709
First received: April 8, 2009
Last updated: November 12, 2013
Last verified: November 2013
  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:


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
Study Completion Date: November 2013
Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 12, 2013
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 July 22, 2014