NCT02653755

The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 671 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This research study is a way of gaining new knowledge about whether patients can omit radiation treatment after undergoing a lumpectomy, also known as "breast conserving surgery". In this trial, we are attempting to identify which patients may not need radiation.

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether it is appropriate for treating a specific disease. The purpose of this study is to determine whether certain patients between the ages of 50 and 75 can safely omit radiation treatment after having a lumpectomy.In this research study, the investigators are using standard laboratory tests along with the Prosigna test to see if certain patients can avoid radiation, without having a higher risk of the cancer coming back in the future. A portion of the participant surgical specimen will be prospectively maintained for future study using institutionally-approved tissue banking procedures. The FDA (the U.S. Food and Drug Administration) has cleared the Prosigna test for generating a risk category and numerical score to assess the risk of distant recurrence, and has cleared us to investigate the use of the Prosigna test for helping with decisions about radiation.

Conditions

• Breast Cancer Radiation

Interventions

Type	Name	Description
DEVICE	Prosigna	Transcriptional profile of 50 genes used for risk stratification.

Timeline

• Start date: 2016-05-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2016-01-12
• Last updated: 2026-01-13

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study