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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 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.

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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.

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

FieldValue
Enrollment Target 202 participants
Start Date 2015-05-27
Est. Completion 2026-05
Phase NA

What the Registry Record Tells You About NCT02400190

The ClinicalTrials.gov registry entry for NCT02400190 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 567-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (64% lower). The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.

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 reports 13 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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