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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: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00863655 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 724 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression-free survival, the primary endpoint in this study, is defined as the time from the date of randomization to the date of first documented radiological progression or death due to any cause. Disease progression was based on the tumor assessment by the local radiologist or investigator using RECIST 1.0 criteria. If a patient did not progress or known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last
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 |
What the finished NCT00863655 record still lists
NCT00863655 is an interventional study that assigns participants to a tested intervention. The registered 724 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Exemestane is the first listed.
NCT00863655 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00863655's enrollment target sits among peer trials
724 491st of 2000 higher than 1,509 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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