Studieoverzicht - 2007-01 ALTTO

 
Number 2007-01 ALTTO
Nickname ALTTO
Status Follow up Date: 31-03-2010
Inclusion closed
Other study number(s) BIG 2-06, N063D, EGF106708
Participating parties/groups BIG
Full title Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) study A randomised, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer
Phase and type Randomized Phase III
Age ≥ 18
Menopausal status Both pre- and postmenopausal
Indication Adjuvant
Subindication HER2+, any HR
Target sample size 8000
Actual accrual 8379 (NL 87) Date: 31-03-2010
Estimated study completion date 31-12-2011
CCMO approval Not applicable Date: Nr: NL17881.060.07
EudraCT nr. 2006-000562-36
Trial Register
METC approval Yes Date: 30-07-2007 METC: Catharina Ziekenhuis Nr: 07-086
Amendments Yes Date: 02-08-2010
KWF-CKS approval No Date: Nr:
News item
Website http://www.bigagainstbreastcancer.org/scientific-projects1/clinical-trials/big-2-06-altto
Sponsor GlaxoSK, BIG
Principal Investigator(s) J.W.R. Nortier
Study manager
Central datamanagement and randomization
Monitoring GlaxoSK, BIG
Local datamanagement
Funding
Extra

Design:

Randomization:
Arm A: trastuzumab 52 wks
Arm B: lapatinib 52 wks
Arm C: trastuzumab (12 wks), 6 wks rest, lapatinib (34 wks)
Arm D: trastuzumab in combination with lapatinib for 1 yr

Objectives:

To compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab
(12 or 18 weeks, according to assigned design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year.

Endpoints:

Primary endpoint:

  • Disease Free Survival

Secondary enpoints:

  • Overall survival (OS)
  • Time to recurrence (TTR)
  • Time to distant recurrence (TTDR)
  • Safety and tolerability
  • Cumulative incidence of brain metastases as the first site of breast cancer recurrence
  • Cohort analysis-cMyc gene amplification; expression levels of PTEN; p95HER2 domain
Main eligibility criteria:
  • pT1-4, N0-3, M0 operable and  HER2neu positive  primary breast cancer
  • Completed definitive surgery and received prior systemic (neo-) adjuvant anthracycline-based chemotherapy
  • LVEF >= 55 following completion of adjuvant chemotherapy
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