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

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ClinicalTrials.gov Identifier: NCT00878709
Recruitment Status : Completed
First Posted : April 9, 2009
Results First Posted : October 9, 2017
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Tracking Information
First Submitted Date  ICMJE April 8, 2009
First Posted Date  ICMJE April 9, 2009
Results First Submitted Date  ICMJE August 10, 2017
Results First Posted Date  ICMJE October 9, 2017
Last Update Posted Date June 11, 2021
Actual Study Start Date  ICMJE July 9, 2009
Actual Primary Completion Date August 21, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2020)
  • Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 [ 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2009)
disease free survival [ Time Frame: five years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2020)
  • Overall Survival (OS) [ Time Frame: Randomization until death due to any cause (up to 119 Months) ]
    OS was defined as the time from randomization to death due to any cause, censored at the last date known alive.
  • Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2 [ 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 at Year 2 [ 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 ]
  • Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 2 [ Time Frame: From randomization until time of event up to 2 years ]
    Percentage of Participants with TTDR events is reported. TTDR 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 at Year 2 [ 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2009)
Common Terminology for Adverse Events (CTCAE) version 3 [ Time Frame: duration of subject's participation on active portion of study ]
Current Other Pre-specified Outcome Measures
 (submitted: November 19, 2020)
  • Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 5 [ Time Frame: From randomization until time of event up to 5 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 5 by Treatment Arms [ Time Frame: From randomization until time of event up to 5 years ]
  • Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 5 [ Time Frame: From randomization until time of event up to 5 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.
  • Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 5 [ Time Frame: From randomization until time of event up to 5 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.
  • Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 5 [ Time Frame: From randomization until time of event up to 5 years ]
    Percentage of Participants with TTDR events is reported. TTDR is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer.
  • Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 5 [ Time Frame: From randomization until time of event up to 5 years ]
    Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: neratinib
    Other Names:
    • HKI-272
    • Nerlynx
  • Other: placebo
Study Arms  ICMJE
  • Experimental: Neratinib
    240 mg orally daily for one year
    Intervention: Drug: neratinib
  • Placebo Comparator: Placebo
    orally daily for one year
    Intervention: Other: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2015)
2840
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2009)
3850
Actual Study Completion Date  ICMJE October 4, 2019
Actual Primary Completion Date August 21, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • Corrected QT (QTc) interval >0.45 seconds
  • History of gastrointestinal disease with diarrhea as the major symptom.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bahamas,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Colombia,   Croatia,   Czechia,   Denmark,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Lithuania,   Malaysia,   Malta,   Mexico,   Netherlands,   New Zealand,   North Macedonia,   Peru,   Poland,   Romania,   Serbia,   Singapore,   Slovakia,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Argentina,   Chile,   Czech Republic,   Jordan,   Lebanon,   Macedonia, The Former Yugoslav Republic of,   Saudi Arabia
 
Administrative Information
NCT Number  ICMJE NCT00878709
Other Study ID Numbers  ICMJE 3144A2-3004 / B1891004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
Access Criteria:

Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.

Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.

URL: https://pumabiotechnology.com/data_sharing_policy.html
Responsible Party Puma Biotechnology, Inc.
Study Sponsor  ICMJE Puma Biotechnology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Senior Vice President Clinical Science and Pharmacology Puma Biotechnology, Inc.
PRS Account Puma Biotechnology, Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP