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ALTTO (JBCRG-08)
GLOBAL
ALTTO（JBCRG-08）
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 (BIG 2-06 / N063D / EGF 106708.)
- Status
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Study Closed
- Objectives
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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 weeks) followed by a six-week treatment-free interval followed by lapatinib (34 weeks) versus trastuzumab in combination with lapatinib for one year.
- Subjects
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- Endpoints
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Disease-free survival(DFS), 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, Presence or absence of cMyc gene amplification, Expression levels of PTEN, Presence or absence of p95 HER2 domain.
- Trial Period
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July 2007 - February 2011 (Registration: 2 years, Follow-up study: 5 years)
- Lead Principal Investigator
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Masakazu Toi (Department of Surgery, Breast Surgery, Graduate School of Kyoto University)
- Target Sample Size
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140
- Regimen
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Lapatinib and/or Trastuzumab
- Source of Funding
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BIG (Breast International Group), Japan Breast Cancer Research Group (JBCRG)
- Conference Presentation
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- Articles and Publications
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- UMIN-ID
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- jRCT
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- Memo
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- COI Disclosure
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