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IBCSG 36-07/BIG 2-06 (ALTTO) 

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

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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

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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.

Results & Publications


ALTTO Publications

Study Chairs
BrEAST: Dr. Martine Piccart - Brussels, Belgium
NCCTG: Dr. Edith Perez - Jacksonville, USA

Statistician
Prof. Richard Gelber

Trial Monitors
Giuseppe Achille, Carmen Comune,  Lionel Nobs

IBCSG Coordinating Center, Bern, Switzerland
Phone: +41 31 511 94 00
Fax: +41 31 511 94 01
Email: altto@ibcsg.org

Date of Activation
April 11, 2007

Date of Closure
August 31, 2011
Targeted Accrual
8000 patients

Link to the ALTTO Trial
www.alttotrials.com


Results Publications Results & Publications


News

14.06.2020:
Save the date and join the IBCSG Pink Ladies! June 14, 2020

20.03.2020:
The next IBCSG Annual Meeting will take place in Barcelona Spain on March 20 and 21, 2020.       

11.11.2019:
New publications are available 

All News

 
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