eagle-i University of Hawaii at ManoaUniversity of Hawaii at Manoa
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Randomised, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer

eagle-i ID


Resource Type

  1. Clinical trial


  1. ClinicalTrials.gov url
  2. Intervention
  3. Intervention
  4. Intervention
  5. Intervention
  6. Intervention
    Adjuvant chemotherapy
  7. Resource Description
    Thes purpose of this research study is to: 1) Find out what effects (good and bad) the study treatment has on the cancer. 2)Compare four different study treatment combinations to see if one is better 3)Find out what effects this study has on patient's quality of life. Because of recent research by NCCTG, the standard treatment for HER2+ breast cancer now includes trastuzumab (Herceptin®). However, not all patients with HER2+ breast cancer do better with trastuzumab, so investigators are trying to find out why. GW572016 (lapatinib, brand name: Tykerb®) is a drug that is taken every day by mouth. This study is comparing trastuzumab to lapatinib and each drug alone to two combinations of trastuzumab and lapatinib. The four treatments being studied here are: Group 1 - The standard treatment - trastuzumab alone for one year Group 2 - Lapatinib alone for one year Group 3 - Trastuzumab for 12 weeks followed by a 6 week break, and then lapatinib for 34 weeks Group 4 - Trastuzumab and lapatinib together for one year.
  8. Contact
    Berenberg, Jeffrey
  9. PI
    Berenberg, Jeffrey
  10. Topic
    breast cancer
  11. Study Population
    Males and females 18 years and older with non-metastatic operable primary invasive adenocarcinoma of the breast, known hormone receptor status (ER/PgR or ER alone), over expression and/or amplification of HER2 in the invasive component of the primary tumour. Tumor must be adequately excised, axilla must be dissected, patients must be axillary node positive or node-negative with tumor greater than or equal to 1.0 cm, and must have received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen.
  12. Funded by
    Cancer Trials Support Unit
  13. Phase
    Phase 3 clinical trial
  14. Performed by
    Clinical Protocol & Data Management Shared Resource
Provenance Metadata About This Resource Record
Copyright © 2016 by the President and Fellows of Harvard College
The eagle-i Consortium is supported by NIH Grant #5U24RR029825-02 / Copyright 2016