Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study
Status:
Completed
Trial end date:
2019-12-23
Target enrollment:
Participant gender:
Summary
This is a randomised, open label multicenter Phase III study comparing the efficacy of
neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant
lapatinib and trastuzumab plus paclitaxel given as neoadjuvant treatment in HER2/ErbB2
over-expressing and/or amplified primary breast cancer.
Patients will be randomised to receive either: lapatinib 1500 mg daily, trastuzumab 4 mg/kg
intravenous (IV) load followed by 2 mg/kg IV weekly, or lapatinib 1000 mg daily with
trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for a total of 6 weeks. After this
biological window, patients on monotherapy arms will continue on the same targeted therapy
plus weekly paclitaxel 80 mg/m^2 for a further 12 weeks, up to definitive surgery. In the
combination arm, patients will receive lapatinib 750 mg daily in combination with trastuzumab
2 mg/kg IV plus weekly paclitaxel 80mg/m^2 IV for a further 12 weeks, up to definitive
surgery. After surgery, patients will receive three courses of adjuvant chemotherapy with
5-Fluorouracil Epirubicin Cyclophosphamide (FEC) followed by the same targeted therapy as in
the biological window of the neoadjuvant setting for a further 34 weeks (in the combination
arm, lapatinib dose will be 1000 mg daily in combination with trastuzumab). The planned total
duration of the anti-HER2 therapy one year.
Primary objective is to evaluate and compare the rate of pathological complete response (pCR)
at the time of surgery in patients with HER2/ErbB2 overexpressing or amplified operable
breast cancer randomised to lapatinib followed by lapatinib plus paclitaxel versus
trastuzumab followed by trastuzumab plus paclitaxel versus lapatinib in combination with
trastuzumab followed by lapatinib, trastuzumab plus paclitaxel.
Phase:
Phase 3
Details
Lead Sponsor:
Novartis Pharmaceuticals
Collaborators:
Breast International Group SOLTI Breast Cancer Research Group