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NCT01617668 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 209
- Enrollment target
NCT01617668: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01617668 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 209 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01617668, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 209 participants
- Enrollment target
Study Summary
To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer whose tumors are positive for a defined pattern of gene expression
Primary Outcome
pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on Bayesian design using a binomial distribution for the data with a beta prior. The measurement type used for this analysis is posterior median an
Interventions
- DRUG paclitaxel
- DRUG LCL161
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT01617668 record still lists
NCT01617668 is an interventional study that assigns participants to a tested intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% higher).
The record links to 0 conditions, and to 2 interventions - of which paclitaxel is the first listed.
NCT01617668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01617668 about?
NCT01617668 is a clinical study titled "A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer". To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer whose tumors are positive for a defined pattern of gene expression
What is the current status of trial NCT01617668?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 209 participants. The study started on 2012-08. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01617668?
The interventions under investigation include: paclitaxel (DRUG), LCL161 (DRUG).
Who is sponsoring clinical trial NCT01617668?
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 NCT01617668's enrollment target sits among peer trials
209 294th of 2000 higher than 1,707 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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