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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Undergo image-guided intensity-modulated APBI
Undergo image-guided intensity-modulated APBI
Undergo image-guided intensity-modulated APBI
Lumpectomy
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method
Acceptability of the definition of treatment targets by MRI, radiation virtual IMRT plans and completion of treatment (APBI and surgery).
Time frame: 4-6 weeks post-APBI
Acute surgical and radiotherapy toxicity as scored by the National Cancer Institute Common Toxicity Criteria (NCI CTCAE) version 4.0
Time frame: Up to 4 weeks post-surgery
Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0
Time frame: Up to 5 years
Cosmetic outcome by the physician and patient
Time frame: At year 1
Cosmetic outcome by the physician and patient
Time frame: At year 3
In-breast recurrence
Time frame: Up to 5 years
Regional recurrence
Time frame: Up to 5 years
Distant metastases
Time frame: Up to 5 years
Disease free survival
Time frame: Up to 5 years
Overall survival
Time frame: Up to 5 years
Exploratory evaluation of patient breast cancer tissue and serum for CSCs, biomarkers and miRNAs
Correlative analyses
Time frame: Up to 4 weeks post-surgery
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