Accelerated Partial Breast Irradiation Study

Studies have shown that giving radiation therapy to the breast after lumpectomy helps keep
cancer from coming back in the breast. The purpose of this study is to see if partial breast
irradiation (PBI) at SRMH Hahn Cancer Center is as good as partial breast irradiation
performed in other centers in the United States in keeping cancer from coming back in the
breast. Whole breast irradiation (WBI) is a standard treatment after a lumpectomy. WBI is
radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. PBI is a new
method of delivering radiation only to the area of the breast where the cancer was removed.
PBI is given 2 times a day for 5 days. PBI may be given over a period of 5 to 10 days. This
newer treatment is currently being compared with WBI in a randomized trial. Thus far,
patients at low risk for cancer recurrence who have been treated with PBI have had excellent
outcomes at 5 years post-treatment, but we will not know for sure if PBI is as good as WBI
until the results of the randomized trial are available. However, PBI is commonly being
offered outside of clinical trials in many community hospitals throughout the country. As
radiation oncologists at Sentara RMH Hahn Cancer Center, we wanted to offer patients in our
community the same opportunity to have this treatment, but also wanted to ensure close
follow-up of all patients treated with this method, to be sure our results are similar to
those of patients reported in our professional literature. There are two different methods of
PBI that are being used at SRMH Hahn Cancer Center: Balloon brachytherapy and 3-D conformal
external beam irradiation. This study will learn about the good and bad effects of radiation
therapy. The study also will learn about the feelings women have about how their breast looks
after surgery and radiation therapy.

Inclusion Criteria:

- The patient must consent to be in the study and must have signed an approved consent
form approved by Sentara RMH Medical Center's IRB.

- Patients must be >/= 50 years or postmenopausal.

- The patient must have stage 0 or 1 breast cancer.

- On histological examination, the tumor must be DCIS or invasive non- lobular carcinoma
of the breast.

- Surgical treatment of the breast must have lumpectomy. The margins of the resected
specimen must be histologically free of tumor (DCIS and in- vasive) by 2 mm or more.
Reexcision of surgical margins is permitted.

- Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 2 cm
or less. Mucinous or tubular histologies maximum size may be up to 3 cm.

- Patients with invasive breast cancer are required to have axillary staging which can
include sentinel node biopsy alone (if sentinel node is negative), sentinel node
biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary
nodes including the sentinel nodes (if sentinel node is positive), or axillary
dissection alone (with a minimum of 6 axillary nodes.) (Axillary staging is not
required for patients with DCIS).

- The patient must begin treatment within 9 weeks following the last surgery for breast
cancer (lumpectomy, re-excision of margins, or axillary staging procedure).

- Patients must have an estrogen receptor (ER) and progesterone receptor (PR) analysis
performed on the primary tumor prior to enrollment.

- The target lumpectomy cavity must be clearly delineated and the ratio of target
lumpectomy cavity/whole breast reference volume must be postoperative CT scan.

- Patients are eligible if, based on the postoperative CT scan, PBI is judged to be
technically deliverable by either 3D conformal radiation therapy or balloon
brachytherapy.

- At the time of study entry, patients must have had an H&P within 4 months and a
bilateral mammogram within 6 months.

- Patients with a history of non-breast malignancies are eligible if they have been
disease-free for 5 or more years prior to study entry and are deemed by their
physician to be 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: Men are not eligible for this study. Women with one or more of the
following conditions are ineligible for this study.

- Stage II, Stage III, or Stage IV Breast Cancer

- Histologically positive axillary on non-axillary nodes.

- Palpable or radiographically suspicious ipsilateral or contralateral axillary,
supraclavicular, infraclavicular, or internal mammary nodes, unless there is
histologic confirmation that these nodes are negative for tumor.

- Suspicious microcalcifications, 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.

- Proven multicentric carcinoma (invasive or DCIS) in more than one quadrant or
separated by 4 or more cm.

- Paget's disease of the nipple.

- Synchronous bilateral invasive or non-invasive breast cancer.

- History of invasive breast cancer or DCIS in the ipsilateral breast (Patients with a
history of LCIS treated by surgery alone are eligible).

- Surgical margins that cannot be microscopically assessed or are less than 2 mm at
pathologic evaluation. (if surgical margins are rendered free of disease by
re-excision, the patient is eligible).

- Clear delineation of the extent of the target lumpectomy cavity not possible.

- Treatment plan that includes regional nodal irradiation.

- Any treatment with radiation therapy to the ipsilateral breast, chemo- therapy
biotherapy, and/or hormonal therapy administered for the currently diagnosed breast
cancer prior to study. The only exception is hormonal therapy, which may have been
given for no more than a total of 28 days anytime after diagnosis and before study
entry. For patients receiving chemotherapy, hormonal therapy must stop at or before
study entry and resume following completion of chemotherapy. For patients not
receiving chemotherapy, hormonal therapy may continue.

- Current therapy with any hormonal agents such as raloxifere (Evista), tamoxifen, or
other selective receptor modulators (SERMs), either for osteoporosis or breast cancer
prevention (patients are eligible only if these medications are discontinued prior to
study entry).

- Breast implants. (Patients who have implants removed are eligible)

- Prior ipsilateral breast or thoracic RT for any condition.

- Collagen vascular disease, specifically dermatomyositis with CPK level above normal or
with an active skin rash, systemic lupus erythematosis, or scleroderma.

- Pregnancy or lactation at the time of proposed study entry. Women of reproductive
potential must agree to use an effective non-hormonal method of contraception during
therapy.

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