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Completed

NCT Number: NCT00878709

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sydney West Cancer Trials Centre, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neratinib

Drug

Other names: HKI-272, Nerlynx

Placebo

Other

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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.

  9. 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).

Other outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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).

Sponsors and collaborators

Lead sponsor

Puma Biotechnology, Inc.

Industry

Registry information

Official study 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

Acronym: ExteNET

Important dates

Study start
2009
Primary completion
2014
Study completion
2019
First posted
Apr 9, 2009
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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