The IDEA Study (Individualized Decisions for Endocrine Therapy Alone) (NCT02400190)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (8 items).
Location: Stanford University — Stanford, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Evidence of multifocal or multicentric breast cancer that has not been biopsy-proven negative. Note that MRI is not required for this study, but if performed, evidence of disease beyond the site of the primary tumor in the ipsilateral breast or in the contralateral breast must be biopsy-proven not to be malignant before registration.
- Metastatic disease. Note that no specific staging studies are mandated, but any studies performed must not provide clear evidence of metastatic spread.
- Previous radiation therapy to the breast region
- Prior DCIS or invasive breast cancer
- Bilateral breast cancer
- Prior non-breast invasive malignancy other than non-melanoma skin cancer, unless there has been no evidence of disease for at least 5 years
- Known carrier of a mutation known to predispose towards breast cancer development (including BRCA-1 and BRCA-2). Note: testing for mutation status is not required for this protocol; this criterion applies only to patients who have been tested and have known carrier status.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (13 Sites)
- Stanford University — Stanford, California
- Yale University — New Haven, Connecticut
- Loyola University Medical Center — Maywood, Illinois
- Johns Hopkins University — Baltimore, Maryland
- Harvard University — Cambridge, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- Northwell Health — Lake Success, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- East Carolina University — Greenville, North Carolina
- University of Pennsylvania — Philadelphia, Pennsylvania
- University of Texas Southwestern Medical Center — Dallas, Texas
- Medical College of Wisconsin — Milwaukee, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.