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NCT02400190 · ClinicalTrials.gov registry record · NA
The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)
A NA study of Breast Neoplasms, sponsored by University of Michigan Rogel Cancer Center.
- Active
- Registry status
- NA
- Development phase
- 202
- Enrollment target
- 13
- Study locations
NCT02400190: Active NA study of Breast Neoplasms, sponsored by University of Michigan Rogel Cancer Center.
NCT02400190 is a NA study of Breast Neoplasms that is active but no longer recruiting, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 202 participants, below the 567-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (64% lower). The trial reports 13 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02400190, a NA study of Breast Neoplasms, is active but no longer recruiting, sponsored by University of Michigan Rogel Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 202 participants
- Enrollment target
- 13
- Study locations
Study Summary
This study will collect rates of local/regional recurrence in select patients who do not receive radiation treatment after lumpectomy surgery. These women must be postmenopausal; have hormone receptor-positive, Her2-negative tumors; have Oncotype-DX RS less than or equal to 18; and plan to receive endocrine therapy. In this way, this study seeks to collect prospective data supporting the idea that this is a population at sufficiently low risk of local/regional recurrence that omission of adjuvant radiation might be a reasonable option.
Primary Outcome
All patients will be followed for their clinical outcome for at least 10 years, specifically: for development of recurrence (and site), the salvage therapy type if local disease recurs, for development of distant metastasis, and survival - both overall and breast-cancer specific.
Conditions Studied
Interventions
- OTHER endocrine therapy alone without radiotherapy
Study Locations (13)
New York
- Northwell Health - Lake Success
- Memorial Sloan Kettering Cancer Center - New York
California
- Stanford University - Stanford
Connecticut
- Yale University - New Haven
Illinois
- Loyola University Medical Center - Maywood
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Harvard University - Cambridge
Michigan
- University of Michigan - Ann Arbor
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2015-05-27 |
| Est. Completion | 2026-05 |
| Phase | NA |
What the registry record for NCT02400190 still lists
NCT02400190 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 567-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which endocrine therapy alone without radiotherapy is the first listed.
NCT02400190 lists 13 locations in 12 states (New York, California, Connecticut).
Frequently Asked Questions
What is clinical trial NCT02400190 about?
NCT02400190 is a clinical study titled "The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)". This study will collect rates of local/regional recurrence in select patients who do not receive radiation treatment after lumpectomy surgery. These women must be postmenopausal; have hormone receptor-positive, Her2-negative tumors; have Oncotype-DX RS less than or equal to 18; and plan to receive e...
What is the current status of trial NCT02400190?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 202 participants. The study started on 2015-05-27. Estimated completion is 2026-05.
What conditions does trial NCT02400190 study?
This clinical trial studies the following conditions: Breast Neoplasms.
What interventions are being tested in trial NCT02400190?
The interventions under investigation include: endocrine therapy alone without radiotherapy (OTHER).
Who is sponsoring clinical trial NCT02400190?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02400190 being conducted?
This trial has 13 study locations across California, Connecticut, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02400190's enrollment target sits among peer trials
202 39th of 97 higher than 59 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms 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.
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