Studieoverzicht - 2007-01 ALTTO
| Number | 2007-01 ALTTO | ||||
| Nickname | ALTTO | ||||
| Status | Closed | Date: 01-07-2021 | |||
| Inclusion closed | 31-03-2010 | ||||
| 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 | 8381 (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 | Novartis, BIG | ||||
| Principal Investigator(s) | J.R. Kroep (for NL) | |||
| Study manager | ||||
| Central datamanagement and randomization | ||||
| Monitoring | Novartis, BIG | |||
| Local datamanagement | ||||
| Funding | Novartis (at start: GSK) | |||
| 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
Documents (public):
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