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ALTTO

  • Closed

BOOG 2007-01

General Information

BOOG number

BOOG 2007-01

Nickname

ALTTO

Status

  • Closed
Date: 01/07/2021

Inclusion closed

31/03/2010

Participating parties / group

BIG

Other study number

BIG 2-06, N063D, EGF106708

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

Indication

  • Adjuvant

Subindication

HER2+, any HR

Target sample size

8000

Actual accrual

8381 (NL 87)
Date: 31/03/2010

Estimated study completion date

31/12/2011

Contact

Sponsor

Novartis, BIG

Principal Investigator(s)

J.R. Kroep (for NL)

Monitoring

Novartis, BIG

Funding

Novartis (at start: GSK)

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

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

Regulatory Information

CCMO approval

Yes
Nr: NL17881.060.07

EC approval

Yes
Date: 30/07/2007
Nr:07-086

EC

Catharina Ziekenhuis
Amendments:
Yes
Date Last Amendment: 02/08/2010

EudraCT number

2006-000562-36

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