Breast Cancer: N063D (Hematology Oncology Associates)

N063D A Randomized, Multi-Center, Open-Label, Phase III study of Adjuvant Lapatinib, Trastuzumab, their sequence and their combination in patients with HER2/ERBB2 positive primary breast cancer.

Objective

This purpose of this research study is to find out what effects (good and bad) the study treatment has on patients with early stage HER2 positive (HER2+) breast cancer that has been surgically removed. The study will compare
four different study treatment combinations to see if one is better than the others, and will examine what effects this study has on patients' quality of life.

Because of recent research by North Central Cancer Treatment Group (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 new drug that is taken every day by mouth.  Lapatinib is considered “investigational” in this study.  “Investigational” means that the FDA has not approved lapatinib as a treatment for early breast cancer.

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 18 weeks followed by a 6-week break, and then lapatinib for up to 28 weeks

Group 4 - Trastuzumab and lapatinib together for one year

The true benefit of taking lapatinib either instead of trastuzumab or with trastuzumab is not known.



Principal Investigator(s)
Shobha Chitneni

Clinical Trial Categories

  • Cancer
  • Breast Cancer
Sponsor(s)
Cancer Trials Support Unit
Contact
Katy D'Aprile, RN, BSN at 563-355-7733

Location

  • Hematology Oncology Associates of the Quad Cities
    1351 East Kimberly Road
    Suite 100
    Bettendorf, IA 52722

Contact Us

For more information about our research program and IRB, please contact:

Research Support Office
563-421-7955

Email