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NCT02291913 · ClinicalTrials.gov registry record · Phase 2
Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer
A Phase 2 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT02291913: Completed Phase 2 study, sponsored by SCRI Development Innovations.
NCT02291913 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02291913, a Phase 2 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
Many patients with ER-positive or PR-positive breast cancer are treated with endocrine therapy. Although most ER/PR-positive tumors initially respond to hormonal therapy, patients often experience disease progression. Everolimus, in combination with exemestane, has shown activity in endocrine-resistant disease. This study will evaluate the efficacy of Everolimus+ anti-estrogen therapy in patients with ER-positive metastatic breast cancer who have progressed after receiving anti-estrogen therapy.
Primary Outcome
PFS is defined as the time from Day 1 of study drug administration to disease progression as defined by RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria, or death on study. Participants who are alive and free from disease progression will be censored at the date of last radiologic tumor assessment. Participants who receive non-protocol therapy (subsequent therapy) prior to incurring an event will be censored at the date of last tumor assessment prior to the start of sub
Interventions
- DRUG Tamoxifen
- DRUG Anastrozole
- DRUG Exemestane
- DRUG Everolimus
- DRUG Fulvestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-12-18 |
| Est. Completion | 2019-01-31 |
| Phase | Phase 2 |
What the finished NCT02291913 record still lists
NCT02291913 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 5 interventions - of which Tamoxifen is the first listed.
NCT02291913 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02291913 about?
NCT02291913 is a clinical study titled "Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer". Many patients with ER-positive or PR-positive breast cancer are treated with endocrine therapy. Although most ER/PR-positive tumors initially respond to hormonal therapy, patients often experience disease progression. Everolimus, in combination with exemestane, has shown activity in endocrine-resist...
What is the current status of trial NCT02291913?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2014-12-18. Estimated completion is 2019-01-31.
What interventions are being tested in trial NCT02291913?
The interventions under investigation include: Tamoxifen (DRUG), Anastrozole (DRUG), Exemestane (DRUG), Everolimus (DRUG), Fulvestrant (DRUG).
Who is sponsoring clinical trial NCT02291913?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02291913's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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