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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.

Undergo image-guided intensity-modulated APBI

accelerated partial breast irradiation

intensity-modulated radiation therapy

image-guided radiation therapy

therapeutic conventional surgery

Sasha Beyer, MD

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.

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.

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

Acceptability of the definition of treatment targets by MRI, radiation virtual IMRT plans and completion of treatment (APBI and surgery).

Ohio State University Comprehensive Cancer Center

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patients With Hormone Responsive Stage 0-I Breast Cancer	NCT02186470	Estrogen Recept... Invasive Ductal... Invasive Ductal... Medullary Ducta... Mucinous Ductal... Papillary Ducta... Progesterone Re... Stage IA Breast... Stage IB Breast... Tubular Ductal ...	accelerated par... intensity-modul... image-guided ra... therapeutic con...	50 Years -	Ohio State University Comprehensive Cancer Center
Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patients With Hormone Responsive Stage 0-I Breast Cancer	NCT02186470	Estrogen Recept... Invasive Ductal... Invasive Ductal... Medullary Ducta... Mucinous Ductal... Papillary Ducta... Progesterone Re... Stage IA Breast... Stage IB Breast... Tubular Ductal ...	accelerated par... intensity-modul... image-guided ra... therapeutic con...	50 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for hormone responsive breast cancer