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ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

NCT00490139 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8381

Last updated 2025-03-21

Study results available
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Summary

This was a four-arm (parallel group) randomized, open-label, multicenter Phase 3 study to investigate the use of a combination of Lapatinib and Trastuzumab, a sequence of Trastuzumab followed by Lapatinib, and Lapatinib alone, compared to Trastuzumab alone in the adjuvant treatment of Human Epidermal Growth Factor Receptor 2 (HER2) positive early breast cancer.

Conditions

  • Neoplasms, Breast

Interventions

DRUG

Lapatinib

Small molecule inhibitor

BIOLOGICAL

Trastuzumab

Antibody

Sponsors & Collaborators

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • National Cancer Institute (NCI)

    collaborator NIH

  • Breast International Group

    collaborator OTHER

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • Novartis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-16
Primary Completion
2013-12-06
Completion
2021-07-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Pakistan
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00490139 on ClinicalTrials.gov