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NCT01923168 · ClinicalTrials.gov registry record · Phase 2
Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 340
- Enrollment target
NCT01923168: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01923168 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 340 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (156% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01923168, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 340 participants
- Enrollment target
Study Summary
The purpose of the study was to determine whether treatment with a PI3K inhibitor plus letrozole led to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer.
Primary Outcome
Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were consider
Interventions
- DRUG Placebo
- DRUG alpelisib
- DRUG buparlisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2014-03-11 |
| Est. Completion | 2017-07-08 |
| Phase | Phase 2 |
What the finished NCT01923168 record still lists
NCT01923168 is an interventional study that assigns participants to a tested intervention. The registered 340 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 (156% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01923168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01923168 about?
NCT01923168 is a clinical study titled "Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women". The purpose of the study was to determine whether treatment with a PI3K inhibitor plus letrozole led to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer.
What is the current status of trial NCT01923168?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 340 participants. The study started on 2014-03-11. Estimated completion is 2017-07-08.
What interventions are being tested in trial NCT01923168?
The interventions under investigation include: Placebo (DRUG), alpelisib (DRUG), buparlisib (DRUG).
Who is sponsoring clinical trial NCT01923168?
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 NCT01923168's enrollment target sits among peer trials
340 137th of 2000 higher than 1,861 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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