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

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1. ClinicalTrials.gov url

   http://www.clinicaltrials.gov/ct2/show/NCT00490139?term=N063D&rank=1

2. Intervention

   Trastuzumab

3. Intervention

   Herceptin

4. Intervention

   Lapatinib

5. Intervention

   Tykerb

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