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NCT02236572 · ClinicalTrials.gov registry record · Phase 2
Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score
A Phase 2 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT02236572: Clinical Trial Phase 2 study, sponsored by Yale University.
NCT02236572 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02236572, a Phase 2 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this study is to see whether adding everolimus to hormone treatment before breast surgery will increase the chances of shrinking the breast cancer in those patients with hormone-responsive breast cancer and a lower Oncotype DX® Recurrence Score ( 25 or less), compared to prior experience with hormone therapy alone. Everolimus is a drug currently approved for use by the United States Food and Drug administration (FDA) for the treatment of patients with advanced or metastatic kidney or breast cancer. Everolimus is considered investigational for non-metastatic breast cancer patients.
Primary Outcome
(PEPI) preoperative endocrine prognostic index. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and estrogen receptor status of the surgical specimen. An HR in the range of 1-2 receives one risk point; a HR in the 2-2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each patient is the sum of all the risk points accumulated from the four factors in the model. A lower PEP
Interventions
- DRUG Everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2014-11-29 |
| Est. Completion | 2021-03-01 |
| Phase | Phase 2 |
Why NCT02236572 stopped before completion
NCT02236572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Everolimus is the first listed.
NCT02236572 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02236572 about?
NCT02236572 is a clinical study titled "Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score". The purpose of this study is to see whether adding everolimus to hormone treatment before breast surgery will increase the chances of shrinking the breast cancer in those patients with hormone-responsive breast cancer and a lower Oncotype DX® Recurrence Score ( 25 or less), compared to prior experie...
What is the current status of trial NCT02236572?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2014-11-29. Estimated completion is 2021-03-01.
What interventions are being tested in trial NCT02236572?
The interventions under investigation include: Everolimus (DRUG).
Who is sponsoring clinical trial NCT02236572?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02236572's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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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