Breast Cancer Study
ALTTO (N063D): A Randomized, Multicenter, Open-Label, Phase III Study of Adjuvant Lapatnib, Trastuzumab, their Sequence and their Combination in Patients with Her-2/ErbB2 Positive Primary Breast Cancer
Protocol ID
08-164
Protocol Description
This purpose of this research study is to:
- Find out what effects (good and bad) the study treatment has on patients with HER2/ErbB2 positive primary breast cancer and their disease
- Compare four different study treatment combinations to see if one is better
- Find out what effects this study has on quality of life
- 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
Eligibility Criteria
Patients with HER2/ErbB2 positive primary breast cancer
Primary Investigator(s)
- Daniel Budman, MD