Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients receive endocrine therapy alone without radiotherapy

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

endocrine therapy alone without radiotherapy

Reshma Jagsi, M.D., Ph.D.

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.

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.

The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

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.

Rutgers Cancer Institute of New Jersey

East Carolina University

Stanford University

Harvard University

Yale University

University of Pennsylvania

Medical College of Wisconsin

Memorial Sloan Kettering Cancer Center

University of Texas Southwestern Medical Center

Johns Hopkins University

Loyola University

University of Michigan Rogel Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)	NCT02400190	Breast Neoplasm...	endocrine thera...	50 Years - 69 Years	University of Michigan Rogel Cancer Center
The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)	NCT02400190	Breast Neoplasm...	endocrine thera...	50 Years - 69 Years	University of Michigan Rogel Cancer Center

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