NCT06008158

Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Pts w/Low Risk, Hormone Responsive Brst Ca

Prospective Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation in Low-Risk, Hormone-Responsive Breast Cancer

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests how well accelerated partial breast irradiation (APBI) delivered once per day works in ensuring an acceptable breast appearance in patients with low risk, hormone responsive breast cancer. APBI uses precise radiation beams to kill cancerous cells in a smaller area of the breast (partial breast) instead of the whole breast or chest area as in standard therapy. Additionally, APBI is given in a shorter course of treatment than whole breast radiation therapy, over fewer days instead of several weeks, with a lower total dose of radiation. APBI is currently given every other business day for a total of 5 treatments with excellent results; however, a shorter treatment duration could have similar or even better results. Undergoing APBI every day on consecutive business days for 5 treatments may result in an improved breast appearance for patients with low risk hormone responsive breast cancer.

Detailed description

PRIMARY OBJECTIVES: I. To establish that APBI delivered once per day (APBI QD) for low-risk breast cancer patients results in acceptable patient-reported cosmetic appearance of the breast at 1 year after completion of APBI QD. SECONDARY OBJECTIVES: I. To determine the long-term patient-reported cosmetic appearance of the breast in patients treated with APBI QD. II. To determine the short-term and long-term physician reported cosmetic appearance of the breast in patients treated with APBI QD. III. To determine the acute and late patient-reported radiation toxicity of APBI QD. IV. To determine the acute and late physician-reported radiation toxicity of APBI QD. V. To determine the cancer control outcomes of APBI QD. EXPLORATORY OBJECTIVES: I. To assess the health-related quality of life in patients treated with APBI QD. II. To determine the long-term blinded physician review of cosmetic appearance of the breast in patients treated with APBI. III. To assess dosimetric parameters associated with cosmesis in patients undergoing APBI QD. OUTLINE: Patients undergo APBI QD on consecutive business days for 5 treatments. Patients follow up at 1 month, 6 months, and 1 year post-APBI and then yearly until 5 years post-APBI.

Conditions

• Anatomic Stage 0 Breast Cancer AJCC v8
• Anatomic Stage IA Breast Cancer AJCC v8
• Estrogen Receptor-Positive Breast Carcinoma
• HER2-Negative Breast Carcinoma

Interventions

Type	Name	Description
RADIATION	Accelerated Partial Breast Irradiation	Undergo APBI

Timeline

• Start date: 2023-09-29
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2023-08-23
• Last updated: 2025-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study