Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer - Full Text View

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

This study is currently recruiting participants.

Verified January 2012 by Pfizer

First Received on April 8, 2009. Last Updated on January 20, 2012 History of Changes

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00878709

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 III

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab HKI-272

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

disease free survival [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	2842
Study Start Date:	July 2009
Estimated Study Completion Date:	October 2013
Estimated 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

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

Contacts

Contact: Pfizer CT.gov Call Center	1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Show 635 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00878709 History of Changes
Other Study ID Numbers:	3144A2-3004, B1891004
Study First Received:	April 8, 2009
Last Updated:	January 20, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

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 February 09, 2012