Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy

This is a non-randomized Phase I-II feasibility study of partial breast irradiation with
accelerated IMRT technique. In this study, patients will be eligible if the estimated risk of
breast cancer elsewhere in the breast (beyond the tumor bed) is low. The radiation treatment
will be available to women who are older than 40 years, have a DCIS (Ductal carcinoma in
situ) or T1, N0, M0, (AJCC classification, version 6.0), non-lobular infiltrating carcinoma
treated with breast-conserving surgery.

Patients will undergo a pre-treatment planning free breathing CT with 5mm cuts in the
treatment position, on a breast board, with both arms extended above their head that will be
used to plan the traditional two field (tangent) plan. An Active Breathing Control (ABC)
device will be used to minimize target motion due to breathing during a second CT scan. The
lumpectomy cavity will be identified and delineated, and margins of approximately 1.5 cm in
three dimensions will be used to allow for subclinical tumor extension and daily set-up
error. The organs at risk (heart, lungs, contralateral breast) will be contoured on both CT
scans. An inverse planning system and optimization tools will be employed in order to achieve
the best IMRT plan (to minimize the dose to the heart, lungs and contralateral breast), that
will be compared to the two field plan. If the IMRT plan is shown to be the optimal one, in
terms of doses to organs at risk, then the patient will be enrolled in the protocol and will
proceed with the treatment. Treatment will start approximately two weeks after the planning
CT is obtained. All patients on protocol will be treated with accelerated radiotherapy, 3.85
Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.

Inclusion Criteria:

- Patient with unifocal histologically proven breast cancer, with or without
calcifications in mammogram.

- DCIS (Ductal carcinoma in situ) (Tis, Stage 0)

- Non-lobular infiltrating carcinoma, maximum of 2 cm in diameter. (T1, Stage I)

- The patient was operated on and the tumor was excised with lumpectomy

- The tumor is reported with negative margins >3 mm, as per our hospital protocol.

- For invasive carcinoma, axillary lymph nodes are negative by sentinel lymph node (SLN)
mapping and biopsy or by formal axillary lymph node dissection.

- The patient is over 40 years old with life expectancy of at least 5 years

- Karnofsky status must be at least 70. See appendix I.

- Pre- and post-menopausal women are eligible for entry.

- The patient must be aware of the neoplastic nature of her disease and must be willing
to consent after being informed of the potential benefits, side effects and risks of
radiotherapy. Institutional Review Board approval of this protocol and a consent form
is required.

Exclusion Criteria:

- No concurrent or neoadjuvant chemotherapy is allowed. Patient is permitted to be
treated with chemotherapy or hormone therapy only after completion of the radiation
treatment.

- Patients with diffuse calcifications, multifocal or multicentric disease,
lymph-vascular invasion are excluded.

- Patients cannot participate if there is extensive LCIS (Lobular carcinoma in situ) in
specimen or extensive DCIS.

- Patients are excluded if systemic disease is present or the patient has been
irradiated to the ipsilateral breast or the chest wall.

- Patients who are carriers of BRCA 1/2 mutations or at high risk for hereditary breast
cancer due to strong family history (more than one pre-menopausal family member with
breast cancer or any ovarian cancer) are excluded because of the increased potential
for in-breast recurrence elsewhere in the breast in the absence of whole breast
radiotherapy.

- Patients with scleroderma, or systemic or discoid lupus are excluded due to the
potential for significant radiotherapy associated toxicity.

- Pregnant woman cannot participate in the study.

- Patients who have serious medical problems which would limit survival to <5 years or a
psychiatric condition which would prevent informed consent cannot participate.

- Patients who are unable to lie on their back and raise their arms above their heads in
the treatment planning position for radiotherapy are excluded.

- Patients that have mammographically occult disease are excluded.