Assessing the Cosmesis and Toxicity of Partial Breast Irradiation Using Proton Beam Irradiation

PBI is radiation therapy given only to the area of the breast where the cancer was removed.
The study staff will use proton-beam radiation to deliver the radiation therapy dose in a
more targeted way than other types of radiation, so that less of the healthy tissue is
affected.

Proton-Beam PBI Treatment:

If you take part in this study, you will have proton radiation therapy delivered to the area
of the lumpectomy 2 times per day, at least 6 hours apart, for 5 (or rarely 6) working days
in a row. You will be placed in a cradle and the beam is aimed at the area of interest. You
will not feel anything when the treatment is being delivered. The treatment lasts only a few
minutes, but you may be in the treatment room longer because the radiation therapists will
need to make sure that you are positioned correctly and that the beam is aimed at the correct
area. The study staff will show you a video that helps to explain this process.

Although you will need to be at the proton radiation center 2 times a day for your radiation
therapy, you are free to leave the proton radiation center between the 2 treatments, and you
should be able to do routine daily activities between treatments. This type of radiation does
not stay in your body between treatments or after the final treatment.

End-of-Treatment Tests:

On the last (or next-to-last) day of proton-beam PBI, you will have the following tests
performed:

- Your medical history will be recorded, and you will be asked about any side effects you
have had.

- You will have a physical exam.

- You and your doctor will each fill out the questionnaire about breast changes.

- Photographs will be taken of your breasts to check the appearance of the treated breast
after radiation.

At the end of radiation treatment, you will be asked how much personal time was used and how
much personal money you spent during treatment. This will only take a few minutes to
complete.

Length of Study:

You will receive 5 weekdays of radiation.

Your participation on the study will be over once you have completed the follow-up visits.

Follow-up Tests:

You are being asked to return to the clinic for follow-up testing for up to a total of 10
years. During the first year, there are 4 follow-up visits: about 2 weeks after treatment,
about 6 weeks after treatment, about 6 months after treatment, and about 1 year after
treatment. During the second and third year, you will come to the clinic every 6 months, and
once a year after that for Years 4-10. Some of these visits may be completed by phone call or
email.

During these follow-up visits, the following procedures will occur:

- Your medical history will be recorded, and you will be asked about any side effects you
have had.

- You will have a physical exam.

- You and your doctor will each fill out the questionnaire about breast changes. This will
only take a few minutes to complete.

- Photographs will be taken of your breasts to check the appearance of the treated breast
after radiation.

You will have a mammogram 6 months after treatment, 1 year after treatment, and then once a
year after that for up to 10 years (as part of this study). You should continue having
mammograms once a year after that, as part of your normal medical follow-up and health
screening.

Inclusion Criteria:

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

2. Patients must be >/= 18 years old. (Adenocarcinoma of the breast is not seen in
children)

3. The patient must have stage 0, I, or II breast cancer. If stage II, the tumor size
must be 3 cm or less.

4. On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the
breast.

5. Surgical treatment of the breast must have been lumpectomy. The margins of the
resected specimen must be histologically free of tumor (DCIS and invasive). Reexcision
of surgical margins is permitted.

6. Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm
or less. (Patients with microscopic multifocality are eligible as long as total
pathologic tumor size is 3 cm or less.)

7. 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 (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.

8. The target lumpectomy cavity must be clearly delineated and the target lumpectomy
cavity/whole breast reference volume must be less than or equal to 30% based on the
postoperative/pre-enrollment CT scan.

9. Patients are eligible if, based on the postoperative CT scan, PBI is judged to be
technically deliverable.

10. 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 physician
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:

1. Men are not eligible for this study.

2. T2 (> 3.0 cm), T3, stage III, or stage IV breast cancer.

3. More than 3 histologically positive axillary nodes.

4. Axillary nodes with definite evidence of microscopic or macroscopic extracapsular
extension.

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

6. Suspicious microcalcifications, or densities (in the ipsilateral or contralateral
breast as documented on mammogram or breast ultrasound) unless biopsied and found to
be benign.

7. Non-epithelial breast malignancies such as sarcoma or lymphoma.

8. Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or
separated by 4 or more centimeters.

9. Paget's disease of the nipple.

10. Synchronous bilateral invasive or non-invasive breast cancer.

11. Surgical margins that cannot be microscopically assessed or are positive at pathologic
evaluation. (If surgical margins are rendered free of disease by reexcision, the
patient is eligible.)

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

13. Treatment plan that includes regional nodal irradiation.

14. Prior radiation to the index breast.

15. Documented diagnosis of collagen vascular disease, specifically dermatomyositis with a
CPK level above normal or with an active skin rash, systemic lupus erythematosis, or
scleroderma.

16. Pregnancy or lactation at enrollment.

17. Women of reproductive potential must agree to use an effective non-hormonal method of
contraception during therapy.