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NCT02273973 · ClinicalTrials.gov registry record · Phase 2
A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 334
- Enrollment target
NCT02273973 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 334 participants.
The verdict
NCT02273973, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 334 participants
- Enrollment target
Study Summary
This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets) or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.
Interventions
- OTHER Placebo
- DRUG Letrozole
- DRUG Taselisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 334 participants |
| Start Date | 2014-11-12 |
| Est. Completion | 2017-03-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02273973
The ClinicalTrials.gov registry entry for NCT02273973 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 334 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02273973 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02273973 about?
NCT02273973 is a clinical study titled "A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)". This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2...
What is the current status of trial NCT02273973?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 334 participants. The study started on 2014-11-12. Estimated completion is 2017-03-13.
What interventions are being tested in trial NCT02273973?
The interventions under investigation include: Placebo (OTHER), Letrozole (DRUG), Taselisib (DRUG).
Who is sponsoring clinical trial NCT02273973?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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