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IBCSG 37-07/BIG 1-06 (Neo-ALTTO) 

A randomized, multicenter, open-label, phase III study of neo-adjuvant lapatinib, trastuzumab, and their combination plus paclitaxel in women with HER2/ErbB2 positive primary breast cancer

Neo-Ajuvant Lapatinib and/or Trastuzumab Treatment Optimisation -  Neo-ALTTO


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This three-arm trial is comparing the efficacy and tolerability of neo-adjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus the combination of lapatinib plus trastuzumab plus paclitaxel given as neo-adjuvant treatment in HER2/ErbB2 over-expressing and/or amplified primary breast cancer.

Patients will be randomized to receive either:
- oral lapatinib (1500 mg daily) for 6 weeks
- trastuzumab (4 mg/kg iv load followed by 2 mg/kg iv weekly) for 6 weeks
- oral lapatinib (1000 mg daily) with trastuzumab (4 mg/kg iv load followed by 2 mg/kg weekly) for 6 weeks

After this "biological window", patients will continue on the same targeted therapy plus weekly paclitaxel 80 mg/m2 for a further 12 weeks, up to definitive surgery. After surgery, patients will receive three courses of adjuvant chemotherapy with FEC followed by the same targeted therapy as in the neo-adjuvant setting for a further 34 weeks. The planned total duration of the anti-HER2 therapy will be one year.

Results & Publications


Study Chairs
Dr. José Baselga - Barcelona, Spain
Dr. Holger Eidtmann - Kiel, Germany
BrEAST: Dr. Martine Piccart - Brussels, Belgium

Prof. Richard Gelber

Trial Monitor
Giuseppe Achille
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

Targeted Accrual
450 patients

Results Publications Results & Publications


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

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

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