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

 -  Patient must be ≥ 50 years

 -  Core biopsy demonstrating breast cancer and receptors that are ER or PR positive.

 -  Core tissue must have HER 2 negative followed by current ASCO/CAP guidelines.

 -  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 Mammo/ 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:

 -  Age < 50 years

 -  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 clinical 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 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 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.