NCT03624478

Hypofractionated Radiation Therapy in Treating Participants With Breast Cancer Before Surgery

A Pilot/Phase II Trial of Hypofractionated Radiotherapy to the Whole Breast Alone Before Breast Conserving Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well hypofractionated radiation therapy works in treating participants with breast cancer before surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Detailed description

PRIMARY OBJECTIVES: I. To determine the pathologic complete response (pCR) rate after hypofractionated radiotherapy to the whole breast alone, based on the postsurgical specimen. SECONDARY OBJECTIVES: I. To evaluate acute and late toxicity with preoperative radiation including grade \>= 2 pneumonitis. II. To estimate the 5-year locoregional control, distant recurrence, invasive disease-free survival, cause-specific survival, and overall survival. CORRELATIVE AND EXPLORATORY OBJECTIVES: I. To evaluate patient-reported outcomes. II. To evaluate clinical features, treatment technique, dose-volume parameters, histologic and genetic variants associated with adverse events, and fair and poor cosmetic outcomes or unplanned surgical intervention. III. Evaluate tumor mutation signatures before and after radiation; correlate tumor mutation signatures before and after radiation with pathologic information at the time of surgery. IV. To describe the pathologic changes seen in breast cancer patients with preoperative radiation. OUTLINE: Participants undergo hypofractionated radiation therapy daily for 5 days, then undergo standard of care surgery 4-16 weeks after radiation therapy. After completion of study treatment, participants are followed up at 12 weeks, 6, 12, 24, and 36 months, and 5 years after radiation therapy.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage IA Breast Cancer AJCC v8
• Anatomic Stage IB Breast Cancer AJCC v8
• Anatomic Stage IIA Breast Cancer AJCC v8
• Prognostic Stage I Breast Cancer AJCC v8
• Prognostic Stage IA Breast Cancer AJCC v8
• Prognostic Stage IB Breast Cancer AJCC v8
• Prognostic Stage IIA Breast Cancer AJCC v8

Interventions

Type	Name	Description
RADIATION	Hypofractionated Radiation Therapy	Undergo hypofractionated radiation therapy

Timeline

• Start date: 2018-11-20
• Primary completion: 2021-06-30
• Completion: 2025-09-24
• First posted: 2018-08-10
• Last updated: 2025-11-26
• Results posted: 2022-12-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study