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NCT01160211 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 369
- Enrollment target
NCT01160211: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01160211 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 369 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01160211, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 369 participants
- Enrollment target
Study Summary
A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).
Primary Outcome
The Number of Participants with Progression free survival (PFS) events in the Lapatinib + Trastuzumab + Aromatase Inhibitor (AI) arm vs. Trastuzumab + Aromatase Inhibitor (AI) arm was based on assessments by the Investigator.
Interventions
- DRUG Trastuzumab
- DRUG Aromatase Inhibitor
- DRUG Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 369 participants |
| Start Date | 2011-05-05 |
| Est. Completion | 2022-06-06 |
| Phase | Phase 3 |
What the finished NCT01160211 record still lists
NCT01160211 is an interventional study that assigns participants to a tested intervention. The registered 369 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT01160211 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01160211 about?
NCT01160211 is a clinical study titled "A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer". A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).
What is the current status of trial NCT01160211?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 369 participants. The study started on 2011-05-05. Estimated completion is 2022-06-06.
What interventions are being tested in trial NCT01160211?
The interventions under investigation include: Trastuzumab (DRUG), Aromatase Inhibitor (DRUG), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT01160211?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01160211's enrollment target sits among peer trials
369 995th of 2000 higher than 1,005 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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