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

design 37 07 Neo ALTTO

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.

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


Statistician
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: This email address is being protected from spambots. You need JavaScript enabled to view it.

Date of Activation
April 11, 2007

Targeted Accrual
450 patients

Final Accrual
455 patients

Date of closure
December 23, 2009

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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