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 Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Study - ALTTO

Design 1

design 36 07 ALTTO 1

Initiation of targeted therapy after completing all (neo) adjuvant chemotherapy

Patients will receive either trastuzumab 8 mg/kg IV loading dose followed by 6mg/kg IV every 3 weeks for 1 year (52 weeks), oral lapatinib 1500 mg daily for 1 year (52 weeks), weekly trastuzumab for 12 weeks (4 mg/kg IV loading dose followed by 2 mg/kg IV weekly) followed by a 6-week treatment-free interval followed by oral lapatinib 1500 mg daily for 34 weeks (total: 52 weeks of treatment) or oral lapatinib 1000 mg daily in combination with trastuzumab 8 mg/kg IV loading dose followed by 6mg/kg IV every 3 weeks for 1 year (52 weeks).

Design 2

design 36 07 ALTTO 2

In patients scheduled to receive taxanes after anthracyclines and together with the targeted agents, paclitaxel will be administered concomitantly with the targeted therapy and according to a weekly schedule (80mg/m2 IV for 12 weeks). When dosed concomitantly with paclitaxel, the weekly schedule of trastuzumab will be used (4 mg/kg IV loading dose followed by 2 mg/kg IV weekly). After completion of paclitaxel, trastuzumab will revert to the three-weekly schedule (6 mg/kg without loading dose) and radiotherapy will be started, if indicated. Docetaxel may become an option pending the results of ongoing safety studies in combination with lapatinib.

International Breast
Cancer Study Group

Effingerstrasse 40
3008 Bern, Switzerland

Contact
Phone: +41 31 511 94 00
E-mail: ibcsgcc@ibcsg.org

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