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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: Completed Phase 2 study, sponsored by Genentech.
NCT02273973 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 334 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (151% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Objective response rate (ORR) was defined as proportion of participants achieving complete response (CR) or partial response (PR). As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
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 |
What the finished NCT02273973 record still lists
NCT02273973 is an interventional study that assigns participants to a tested intervention. The registered 334 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 (151% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02273973 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02273973's enrollment target sits among peer trials
334 143rd of 2000 higher than 1,857 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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