Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02340221 · ClinicalTrials.gov registry record · Phase 3
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 631
- Enrollment target
NCT02340221 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 631 participants.
The verdict
NCT02340221, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 631 participants
- Enrollment target
Study Summary
This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.
Interventions
- DRUG Placebo
- DRUG Fulvestrant
- DRUG Taselisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 631 participants |
| Start Date | 2015-04-09 |
| Est. Completion | 2021-06-29 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02340221
The ClinicalTrials.gov registry entry for NCT02340221 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 631 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02340221 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02340221 about?
NCT02340221 is a clinical study titled "A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy". This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (H...
What is the current status of trial NCT02340221?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 631 participants. The study started on 2015-04-09. Estimated completion is 2021-06-29.
What interventions are being tested in trial NCT02340221?
The interventions under investigation include: Placebo (DRUG), Fulvestrant (DRUG), Taselisib (DRUG).
Who is sponsoring clinical trial NCT02340221?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.