Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00863655 · ClinicalTrials.gov registry record · Phase 3
Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 724
- Enrollment target
NCT00863655 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 724 participants.
The verdict
NCT00863655, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 724 participants
- Enrollment target
Study Summary
There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.
Interventions
- DRUG Exemestane
- DRUG Everolimus
- DRUG Everolimus Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 724 participants |
| Start Date | 2009-06-03 |
| Est. Completion | 2014-12-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00863655
The ClinicalTrials.gov registry entry for NCT00863655 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 724 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 Exemestane is the first listed.
NCT00863655 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00863655 about?
NCT00863655 is a clinical study titled "Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole". There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and sa...
What is the current status of trial NCT00863655?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 724 participants. The study started on 2009-06-03. Estimated completion is 2014-12-04.
What interventions are being tested in trial NCT00863655?
The interventions under investigation include: Exemestane (DRUG), Everolimus (DRUG), Everolimus Placebo (DRUG).
Who is sponsoring clinical trial NCT00863655?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 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.