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NCT00490139 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Neoplasms, Breast, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
8,381
Enrollment target
20
Study locations

NCT00490139 is a Phase 3 study of Neoplasms, Breast that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 8,381 participants, above the 137-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (6018% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT00490139, a Phase 3 study of Neoplasms, Breast, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
8,381 participants
Enrollment target
20
Study locations

Study 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 Studied

Neoplasms, Breast

Interventions

  • BIOLOGICAL Trastuzumab
  • DRUG Lapatinib

Study Locations (20)

California

  • Novartis Investigative Site - Duarte
  • Novartis Investigative Site - Fairfield
  • Novartis Investigative Site - La Jolla
  • Novartis Investigative Site - La Jolla
  • Novartis Investigative Site - Loma Linda
  • Novartis Investigative Site - Martinez
  • Novartis Investigative Site - Marysville
  • Novartis Investigative Site - Mountain View
  • Novartis Investigative Site - Oakland
  • Novartis Investigative Site - Pleasanton
  • Novartis Investigative Site - Sacramento
  • Novartis Investigative Site - San Francisco

Colorado

  • Novartis Investigative Site - Aurora
  • Novartis Investigative Site - Boulder
  • Novartis Investigative Site - Colorado Springs
  • Novartis Investigative Site - Denver

Alabama

  • Novartis Investigative Site - Mobile

Alaska

  • Novartis Investigative Site - Anchorage

Arizona

  • Novartis Investigative Site - Tucson

Arkansas

  • Novartis Investigative Site - Jonesboro

Trial Details

FieldValue
Enrollment Target 8,381 participants
Start Date 2007-05-16
Est. Completion 2021-07-01
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00490139

The ClinicalTrials.gov registry entry for NCT00490139 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 8,381 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 137-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (6018% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neoplasms, Breast appearing as the primary indexed condition, and to 2 interventions - of which Trastuzumab is the first listed.

NCT00490139 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Colorado, Alabama.

Frequently Asked Questions

What is clinical trial NCT00490139 about?

NCT00490139 is a clinical study titled "ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D". 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 Epiderma...

What is the current status of trial NCT00490139?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 8,381 participants. The study started on 2007-05-16. Estimated completion is 2021-07-01.

What conditions does trial NCT00490139 study?

This clinical trial studies the following conditions: Neoplasms, Breast.

What interventions are being tested in trial NCT00490139?

The interventions under investigation include: Trastuzumab (BIOLOGICAL), Lapatinib (DRUG).

Who is sponsoring clinical trial NCT00490139?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00490139 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.