The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02400190 |
Recruitment Status :
Active, not recruiting
First Posted : March 26, 2015
Last Update Posted : December 17, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Neoplasms | Other: endocrine therapy alone without radiotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 202 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The IDEA Study (Individualized Decisions for Endocrine Therapy Alone) |
Study Start Date : | March 2015 |
Estimated Primary Completion Date : | March 2026 |
Estimated Study Completion Date : | March 2026 |

Arm | Intervention/treatment |
---|---|
Experimental: Endocrine therapy alone
Patients receive endocrine therapy alone without radiotherapy
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Other: endocrine therapy alone without radiotherapy
Patients will not receive radiotherapy, which is the current standard for treatment for their type of breast cancer. |
- Loco-regional Recurrence [ Time Frame: 5 years of follow up ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Postmenopausal status, as defined by (a) patients age 60 or greater, or, (b) patients age 50-69 with either (a) s/p bilateral oophorectomy, or, (b) intact uterus without menses in the past 12 months, or, (c) biochemical confirmation of postmenopausal status.
- Histopathological confirmation of Stage 1 (pT1N0M0) invasive breast cancer status post breast conserving surgery
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Negative axillary nodes (isolated tumor cells with no cluster measuring >0.2mm allowed)
- Allowable options for axillary staging include:
- Sentinel node biopsy only
- Sentinel node biopsy followed by axillary dissection
- Axillary dissection only
- Margins of excision ≥2mm
- ER+, PR+, Her2 - using the current College of American Pathologists guidelines
- Oncotype-DX RS ≤ 18
- Disease must be unifocal on clinical, radiologic, and pathologic examination
- Registration within 90 days of last surgical procedure for breast cancer treatment
- Patient must willingly sign study specific informed consent prior to study entry
- Patient must be a candidate for and willing to take endocrine therapy for minimum of 5 years (aromatase inhibitor or tamoxifen). Patients who have already begun endocrine therapy after lumpectomy are eligible.
- Patient must have had breast imaging (mammogram or MRI) of the ipsilateral breast within 6 months and contralateral breast within 1 year of study entry.
- Patient must have Zubrod performance status 0-2
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400190
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 | |
United States, Connecticut | |
Yale University | |
New Haven, Connecticut, United States, 06520 | |
United States, Illinois | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States | |
United States, Massachusetts | |
Harvard University | |
Cambridge, Massachusetts, United States, 02138 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, New Jersey | |
Rutgers Cancer Institute of New Jersey | |
New Brunswick, New Jersey, United States, 08901 | |
United States, New York | |
Northwell Health | |
Lake Success, New York, United States, 11042 | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, North Carolina | |
East Carolina University | |
Greenville, North Carolina, United States, 27853 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75390 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Principal Investigator: | Reshma Jagsi, M.D., Ph.D. | University of Michigan |
Other Publications:
Responsible Party: | University of Michigan Rogel Cancer Center |
ClinicalTrials.gov Identifier: | NCT02400190 |
Other Study ID Numbers: |
UMCC 2014.111 |
First Posted: | March 26, 2015 Key Record Dates |
Last Update Posted: | December 17, 2021 |
Last Verified: | December 2021 |
radiation lumpectomy favorable biology omission |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |