104IN - China's experience in joining the large adjuvant ALTTO trial

Date 29 September 2012
Event ESMO Congress 2012
Session ESMO-CSCO Joint symposium: Building the clinical trials of the future
Topics Bioethics, Legal, and Economic Issues
Presenter Ze Fei Jiang
Authors Z.F. Jiang
  • -, 307 Hospital Amms China, 100071 - Beijing/CN

Abstract

The ALTTO study is a randomized, open label multi-center phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas and will be randomized to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in each treatment regimen. There were 5 sites in China which participated in the ALTTO study. From March 2008 to April 2010, a total of 441 patients were randomized to one of four treatment regimens within two design schemas (Design 2B was not applicable in China). The table shows 100 patients from our cancer center.

Disclosure

The author has declared no conflicts of interest.

Group Number Withdraw* Recurrence
Trastuzumab alone 26 1 3
Lapatinib alone ** 23 2 0
Lapatinib + Trastuzumab *** 25 2 0
Trastuzumab → Lapatinib 26 0 0

• * 3 subjects due to AE, 2 subject due to Personal reason • ** 2 subjects transfer to Trastuzumab alone therapy due to AE • *** 1subjects transfer to Trastuzumab alone therapy due to AE All the subjects in China have finished study treatment and are now in follow up.