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

PRIMARY OBJECTIVES:

I. Establish the feasibility for preoperative APBI delivered with intensity-modulated
radiation therapy (IMRT) in the prone position using daily computed tomography (CT) guidance
for stage 0-I breast cancer patients who are intended to undergo a lumpectomy for breast
conserving therapy.

SECONDARY OBJECTIVES:

I. To determine the acute and late surgical and radiation toxicity of preoperative APBI
delivered with IMRT in the prone position.

II. To document the cosmetic appearance of the breast when treated with preoperative APBI
IMRT in the prone position.

III. Establish the percentage of patients that can meet dosimetric goals and normal tissue
constraints if treated with preoperative APBI IMRT in the prone position.

OUTLINE:

Patients undergo image-guided intensity-modulated APBI twice daily (BID) for 5 days over a
period of 5-10 days for a total of 10 fractions. Within 4-6 weeks post-APBI, patients
undergo lumpectomy.

After completion of treatment, patients are followed up at 4 weeks and then at 1, 2, and 3
years.

Inclusion Criteria:

- The patient must consent to be in the study and must have signed an approved consent
form conforming with federal and institutional guidelines

- Core biopsy demonstrating breast cancer and receptors that are estrogen receptor
positive or negative (ER +/-) PR positive

- Core tissue must have human epidermal growth factor receptor 2 (HER 2) testing

- The patient must have clinical node negative, stage I breast cancer

- The surgical treatment must be intended to be a lumpectomy

- The biopsy site must have been demarcated by a clip(s)

- Gross disease must be unifocal on mammogram/magnetic resonance imaging (MRI) imaging

- Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis
performed on core biopsy

- Patient must be able to tolerate lying in the prone position with arms extended
forward

- Must be able to tolerate MRI scan with contrast

- At the time of enrollment, patients must have had bilateral mammograms within 6
months

- Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6
weeks post APBI

- Patients with a history of non-breast malignancies are eligible if they have been
disease-free for 5 or more years prior to enrollment and are deemed by their
physicians to be at low risk for recurrence; patients with the following cancers are
eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the
cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous
cell carcinoma of the skin

Exclusion Criteria:

- Hormone unresponsive breast cancer

- T-2 (> 3.0 cm), T-3, stage III, or stage IV breast cancer

- N-1, N-2, or N-3 pathologic axillary nodes

- Mastectomy intended

- Unwilling to undergo anti-endocrine therapy

- Suspicious microcalcification, densities, or palpable abnormalities ( in the
ipsilateral or contralateral breast) unless biopsied and found to be benign

- Non-epithelial breast malignancies such as sarcoma or lymphoma

- Paget's disease of the nipple

- Proven multicentric carcinoma (invasive or ductal carcinoma in situ [DCIS]) in more
than one quadrant or separated by > 4 centimeters

- Any prior treatment with radiation therapy, chemotherapy, biotherapy, or hormone
therapy for the currently diagnosed breast cancer prior to study enrollment

- Prior breast or thoracic radiation therapy (RT) for any condition

- Psychiatric of addictive disorders or other condition that in the opinion of the
investigator would preclude the patient from meeting the study requirements