The IDEA Study (Individualized Decisions for Endocrine Therapy Alone) (NCT02400190) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)
United States202 participantsStarted 2015-05-27
Plain-language 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.
Who can participate
Age range50 Years – 69 Years
SexFEMALE
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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…