NCT05528133

Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer

Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
RADIATION	Genomically Guided Radiation Therapy	Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with or without a boost of 10 Gy in 5 fractions to the cavity.
RADIATION	Genomically Guided Radiation Therapy	Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with a boost of 10 Gy in 5 fractions to the cavity.

Timeline

• Start date: 2023-01-25
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2022-09-06
• Last updated: 2026-02-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study