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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:
ClinicalTrials.gov Identifier:
NCT00878709
First Posted: April 9, 2009
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:
  • Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm [ Time Frame: From randomization until time of event up to 2 years ]
    Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.

  • Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms [ Time Frame: From randomization until time of event up to 2 years ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: From time of randomization to death ]
    Overall survival is defined as the time from randomization to death from any cause

  • Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm [ Time Frame: From randomization until time of event up to 2 years ]
    Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any.

  • Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms [ Time Frame: From randomization until time of event up to 2 years ]
  • Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm [ Time Frame: From randomization until time of event up to 2 years ]
    Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause.

  • Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms [ Time Frame: From randomization until time of event up to 2 years ]
  • Time to Distant Recurrence (TTDR) in Neratinib Arm Compared to Placebo Arm [ Time Frame: From randomization until time of event up to 2 years ]
    Time to distant recurrence is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer.

  • Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms [ Time Frame: From randomization until time of event up to 2 years ]
  • Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm [ Time Frame: From randomization until time of event up to 2 years ]
    CNS recurrence is defined as the time from randomization to CNS as the first distant recurrence. Competing events include distant recurrence at other sites as the first distant recurrence and death from any cause prior to distant recurrence.

  • Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2 [ Time Frame: From randomization until time of event up to 2 years ]
    Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).


Enrollment: 2840
Actual Study Start Date: July 9, 2009
Estimated Study Completion Date: November 2020
Primary Completion Date: August 21, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neratinib
240 mg orally daily for one year
Drug: neratinib
Other Names:
  • HKI-272
  • Nerlynx
Placebo Comparator: Placebo
orally daily for one year
Other: placebo

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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 pathologic complete response.

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878709


  Show 493 Study Locations
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
Study Director: Puma Biotechnology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00878709     History of Changes
Other Study ID Numbers: 3144A2-3004
B1891004
First Submitted: April 8, 2009
First Posted: April 9, 2009
Results First Submitted: August 10, 2017
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents