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NCT02955394 · ClinicalTrials.gov registry record · Phase 2
Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by University of Colorado, Denver.
- Active
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 3
- Study locations
NCT02955394: Active Phase 2 study of Breast Cancer, sponsored by University of Colorado, Denver.
NCT02955394 is a Phase 2 study of Breast Cancer that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 61 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02955394, a Phase 2 study of Breast Cancer, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced AR+/ER+/Her2- BC who will have local surgery after \~4 months on treatment.
Primary Outcome
The preoperative endocrine prognostic index (PEPI) is a validated measure of pathologic response to endocrine therapy. It is a model that combines estrogen receptor (ER) level, pathologic tumor site, nodal status, and Ki67 score at the time of surgery to predict subsequent risk of cancer recurrence. PEPI scoring is typically discretized into three risk groups: 0 (low risk of recurrence and best outcome), 1-3 (intermediate risk), and \>= 4 (high risk). This study was concerned only with the dist
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Enzalutamide
Study Locations (3)
Colorado
- University of Colorado - Aurora
New York
- Memorial Sloan Kettering Cancer Center - New York
Tennessee
- West Cancer Center - Germantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2017-09-21 |
| Est. Completion | 2027-02 |
| Phase | Phase 2 |
What the registry record for NCT02955394 still lists
NCT02955394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Fulvestrant is the first listed.
NCT02955394 reports a single indexed study location in Colorado, New York, Tennessee.
Frequently Asked Questions
What is clinical trial NCT02955394 about?
NCT02955394 is a clinical study titled "Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer". This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced AR+/ER+/Her2- BC who will have local surgery after \~4 months on treatment.
What is the current status of trial NCT02955394?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2017-09-21. Estimated completion is 2027-02.
What conditions does trial NCT02955394 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02955394?
The interventions under investigation include: Fulvestrant (DRUG), Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT02955394?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02955394 being conducted?
This trial has 3 study locations across Colorado, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02955394's enrollment target sits among peer trials
61 735th of 1224 higher than 490 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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