The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

Study Overview
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Brief Summary
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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.

Detailed Description
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This study's primary aim is to determine rates of recurrence with the innovative approach of considering tumor biology to select patients who may avoid radiation, with restriction of eligibility to women aged 50-69 with hormone-sensitive, Her2-negative tumors with Oncotype-DX RS ≤ 18 who plan to receive endocrine therapy. In this way, this study seeks to collect prospective data supporting the idea that this is a population at low risk of LRR in whom omission of adjuvant radiation is reasonable.

Official Title
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The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Other: endocrine therapy alone without radiotherapy


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endocrine therapy alone<br>Patients receive endocrine therapy alone without radiotherapy | Other: endocrine therapy alone without radiotherapy<br>* Patients will not receive radiotherapy, which is the current standard for treatment for their type of breast cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation, lumpectomy, favorable biology, omission