NCT02400190

The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Female
• Age: 50 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
OTHER	endocrine therapy alone without radiotherapy	Patients will not receive radiotherapy, which is the current standard for treatment for their type of breast cancer.

Timeline

• Start date: 2015-05-27
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2015-03-26
• Last updated: 2025-10-07

Locations

13 sites across 1 country: United States