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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.
Results First Submitted: August 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: neratinib
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Neratinib Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Placebo Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year.Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Participant Flow:   Overall Study
    Neratinib   Placebo
STARTED   1420   1420 
COMPLETED   1095   1183 
NOT COMPLETED   325   237 
Withdrawal by Subject                197                120 
Lost to Follow-up                35                33 
Other Reasons                93                84 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm   [ Time Frame: From randomization until time of event up to 2 years ]

2.  Primary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm   [ Time Frame: From randomization until time of event up to 2 years ]

6.  Secondary:   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 ]

7.  Secondary:   Time to Distant Recurrence (TTDR) in Neratinib Arm Compared to Placebo Arm   [ Time Frame: From randomization until time of event up to 2 years ]

8.  Secondary:   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 ]

9.  Secondary:   Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm   [ Time Frame: From randomization until time of event up to 2 years ]

10.  Secondary:   Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2   [ Time Frame: From randomization until time of event up to 2 years ]

11.  Secondary:   Overall Survival (OS)   [ Time Frame: From time of randomization to death ]
Results not yet reported.   Anticipated Reporting Date:   07/2019  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Director, Clinical Operations
Organization: Puma Biotechnology, Inc.
phone: +1 (424) 248-6500
e-mail: clinicaltrials@pumabiotechnology.com


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