The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

NCT02400190 | Active Not Recruiting DMC

• 2 other identifiers: UMCC 2014.111HUM00092923
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 13

Brief 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

Breast Neoplasms

Keywords

radiation; lumpectomy; favorable biology; omission

Outcome Measures

Primary Outcomes (1)

• Loco-regional Recurrence

  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.

  5 years of follow up

Study Arms (1)

Endocrine therapy alone

EXPERIMENTAL

Patients receive endocrine therapy alone without radiotherapy

Other: endocrine therapy alone without radiotherapy

Interventions

endocrine therapy alone without radiotherapy OTHER

Patients will not receive radiotherapy, which is the current standard for treatment for their type of breast cancer.

Endocrine therapy alone

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Rutgers Cancer Institute of New Jersey: collaborator
• East Carolina University: collaborator
• Stanford University: collaborator
• Harvard University: collaborator
• Yale University: collaborator
• University of Pennsylvania: collaborator
• Medical College of Wisconsin: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• University of Texas Southwestern Medical Center: collaborator
• Johns Hopkins University: collaborator
• Loyola University: collaborator

Study Sites (13)

Stanford University

Stanford, California, 94305, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Johns Hopkins University

Baltimore, Maryland, United States

Location

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

East Carolina University

Greenville, North Carolina, 27853, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• Mamounas EP, Tang G, Fisher B, Paik S, Shak S, Costantino JP, Watson D, Geyer CE Jr, Wickerham DL, Wolmark N. Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20. J Clin Oncol. 2010 Apr 1;28(10):1677-83. doi: 10.1200/JCO.2009.23.7610. Epub 2010 Jan 11.

  PMID: 20065188 BACKGROUND

• Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.

  PMID: 12393820 RESULT

• Jagsi R, Griffith KA, Harris EE, Wright JL, Recht A, Taghian AG, Lee L, Moran MS, Small W Jr, Johnstone C, Rahimi A, Freedman G, Muzaffar M, Haffty B, Horst K, Powell SN, Sharp J, Sabel M, Schott A, El-Tamer M. Omission of Radiotherapy After Breast-Conserving Surgery for Women With Breast Cancer With Low Clinical and Genomic Risk: 5-Year Outcomes of IDEA. J Clin Oncol. 2024 Feb 1;42(4):390-398. doi: 10.1200/JCO.23.02270. Epub 2023 Dec 7.

  PMID: 38060195 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Reshma Jagsi, M.D., Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: May 27, 2015
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

US (13)