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

NCT00878709 · ExteNET Phase 3Completed

Lead sponsor
Puma Biotechnology, Inc. (Industry)
Enrollment
2,840 (actual)
Start date
9 Jul 2009
Primary completion
21 Aug 2014 (actual)
Study completion
4 Oct 2019
Last update posted
11 Jun 2021

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
2

Interventions

  • neratinib Drug
  • placebo Other

Conditions and primary outcome

  • Breast Cancer

Primary outcome

Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 (From randomization until time of event up to 2 years); Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms (From randomization until time of event up to 2 years)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT00878709 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  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
    Measure
    Number
    Unit
    percentage of participants with events

    • Neratinib vs PlaceboSuperiority

      Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.

      Estimate
      0.66Hazard Ratio (HR)
      95% CI, two-sided
      0.49 to 0.90
      p-value
      0.008
      Method
      Log Rank

Serious adverse events

Time frame: From first dose through 28 days after the last dose, up to two years.

Participants with serious adverse events per group for ExteNET, as posted
GroupAffectedAt risk
Neratinib1031408
Placebo851408

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

7 on PubMed

  1. Overall survival with neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): A randomised, double-blind, placebo-controlled, phase 3 trial.

    European journal of cancer (Oxford, England : 1990) · 2023 May

    PubMed 36898233 (opens in a new tab)DOI 10.1016/j.ejca.2023.02.002 (opens in a new tab)

  2. Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer.

    Future oncology (London, England) · 2019 Jul

    PubMed 31140297 (opens in a new tab)DOI 10.2217/fon-2019-0143 (opens in a new tab)

  3. Effects of neratinib on health-related quality of life in women with HER2-positive early-stage breast cancer: longitudinal analyses from the randomized phase III ExteNET trial.

    Annals of oncology : official journal of the European Society for Medical Oncology · 2019 Apr 1

    PubMed 30689703 (opens in a new tab)DOI 10.1093/annonc/mdz016 (opens in a new tab)

  4. PIK3CA alterations and benefit with neratinib: analysis from the randomized, double-blind, placebo-controlled, phase III ExteNET trial.

    Breast cancer research : BCR · 2019 Mar 11

    PubMed 30867034 (opens in a new tab)DOI 10.1186/s13058-019-1115-2 (opens in a new tab)

  5. Patterns of occurrence and implications of neratinib-associated diarrhea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial.

    Breast cancer research : BCR · 2019 Feb 27

    PubMed 30813966 (opens in a new tab)DOI 10.1186/s13058-019-1112-5 (opens in a new tab)

  6. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial.

    The Lancet. Oncology · 2017 Dec

    PubMed 29146401 (opens in a new tab)DOI 10.1016/S1470-2045(17)30717-9 (opens in a new tab)

  7. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

    The Lancet. Oncology · 2016 Mar

    PubMed 26874901 (opens in a new tab)DOI 10.1016/S1470-2045(15)00551-3 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

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Data integrity

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Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.