NCT02186470

Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patients With Hormone Responsive Stage 0-I Breast Cancer

Feasibility of Assessing Radiation Response With MRI/CT Directed Preoperative Accelerated Partial Breast Irradiation in the Prone Position for Hormone Responsive Early Stage Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI) before surgery in treating older patients with estrogen receptor positive or progesterone receptor positive stage I breast cancer. APBI is a specialized type of radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Detailed description

PRIMARY OBJECTIVES: Establish the feasibility for preoperative APBI delivered with IMRT in the prone position using daily CT guidance for Stage I breast cancer patients who are intended to undergo a lumpectomy for breast conserving therapy. SECONDARY OBJECTIVES: 1. To determine the acute and late surgical and radiation toxicity of preoperative APBI delivered with IMRT in the prone position. 2. To document the cosmetic appearance of the breast when treated with preoperative APBI IMRT in the prone position. 3. Establish the percentage of patients that can meet dosimetric goals and normal tissue constraints if treated with preoperative APBI IMRT in the prone position. 4. Evaluate molecular changes in breast cancer and/or stroma before and after preoperative APBI OUTLINE: Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI, patients undergo lumpectomy. After completion of treatment, patients are followed up at 4 weeks and then every 6 months for 5 years.

Conditions

• Estrogen Receptor-positive Breast Cancer
• Invasive Ductal Breast Carcinoma
• Invasive Ductal Breast Carcinoma With Predominant Intraductal Component
• Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate
• Mucinous Ductal Breast Carcinoma
• Papillary Ductal Breast Carcinoma
• Progesterone Receptor-positive Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Tubular Ductal Breast Carcinoma

Interventions

Type	Name	Description
RADIATION	accelerated partial breast irradiation	Undergo image-guided intensity-modulated APBI
RADIATION	intensity-modulated radiation therapy	Undergo image-guided intensity-modulated APBI
RADIATION	image-guided radiation therapy	Undergo image-guided intensity-modulated APBI
PROCEDURE	therapeutic conventional surgery	Lumpectomy

Timeline

• Start date: 2016-04-29
• Primary completion: 2025-09-04
• Completion: 2025-09-04
• First posted: 2014-07-10
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study