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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: Completed Phase 3 study of Neoplasms, Breast, sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Disease-Free Survival (DFS) was defined as the interval between randomization and the date of first occurrence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer or death without recurrence. Only deaths occurring in participants whose clinical follow-up was ongoing at the time of death and who had no recurrence, contralateral breast cancer (CBC) or second primary malignancy (SPM) reported prior to death were considered as death wit
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 8,381 participants |
| Start Date | 2007-05-16 |
| Est. Completion | 2021-07-01 |
| Phase | Phase 3 |
What the finished NCT00490139 record still lists
NCT00490139 is an interventional study that assigns participants to a tested intervention. Its 8,381 participants enrollment target places it among the larger protocols in the corpus, above the 137-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (6018% higher).
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 names 20 study sites across 6 states, led by 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.
Learn More About Clinical Trials
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Where NCT00490139's enrollment target sits among peer trials
8,381 1st of 9 higher than 9 of 9 other Neoplasms, Breast trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms, Breast trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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