Spots Global Cancer Trial Database for The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

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Trial Identification

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

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

Study ID: NCT02400190

Conditions

Breast Neoplasms

Interventions

endocrine therapy alone without radiotherapy

Study Description

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.

Detailed Description: 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.