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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 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 340 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01923168
The ClinicalTrials.gov registry entry for NCT01923168 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01923168 reports 0 study locations.
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.
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