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

Novartis Pharmaceuticals

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Brief 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.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym
ALTTO
status
COMPLETED
phase
PHASE3
study type
INTERVENTIONAL
enrollment
8381
sponsor
Novartis Pharmaceuticals
conditions
Neoplasms, Breast
interventions
DRUG: Lapatinib; BIOLOGICAL: Trastuzumab
start date
2007-05-16
start date type
ACTUAL
primary completion date
2013-12-06
has results
true
data source
ClinicalTrials.gov
data processed
2026-10-29T09:00:05
modifications
selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Record

Archive ID
nct:NCT00490139
Published
Jun 22, 2007
Updated
Mar 21, 2025
Venue
ClinicalTrials.gov
ClinicalTrials.gov
NCT00490139
Categories
Neoplasms, Breast
License
ClinicalTrials.gov terms (attribution, processing date, modifications noted)
Provenance
clinicaltrials

Topics