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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: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02340221 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 631 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target l
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 |
Why NCT02340221 stopped before completion
NCT02340221 is an interventional study that assigns participants to a tested intervention. The registered 631 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02340221 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02340221's enrollment target sits among peer trials
631 581st of 2000 higher than 1,420 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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