Preoperative Accelerated Partial Breast Irradiation for Triple Negative Breast Cancer Using Proton Beam Scanning

This research study is a Pilot Study, which means this is the first time investigators are
examining this study intervention in participants with triple negative breast cancer.

The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for your
specific disease but it has been approved for other uses.

The investigators believe that proton radiation administered in higher doses over a shorter
time period may help stop cancer from growing while protecting the normal tissue cells.

In this research study, the investigators are researching how well proton radiation works in
treating this type of breast cancer. Proton radiation is currently used in other types of
breast cancer and the investigators believe that the higher doses of proton radiation
administered over a shorter time period may lead to maximum efficacy in treating this type of
breast cancer.

Inclusion Criteria:

- Age at least 40 years

- Core biopsy proven estrogen negative (< 1%), progesterone negative (< 1%), and
HER2-neu negative (+1 by immunohistochemistry and/or FISH ratio < 2.0) invasive breast
cancer

- Unicentric AJCC 7th edition T1N0M0 tumor measuring no greater than 2.0 cm in longest
dimension on initial imaging with either breast MRI and/or mammogram

- ECOG Performance status < 1

- No prior treatment for this diagnosis of cancer

- No prior radiation to the ipsilateral breast, a history of contralateral breast
radiation is permitted

- No clinical or radiographic evidence of malignant regional adenopathy

- No contraindication to breast conserving surgery, sentinel lymph node biopsy, or
radiation therapy

- Ability to understand and willingness to sign a written informed consent document.

- Pregnant females are excluded. Female subjects of childbearing potential must indicate
to their physician that there is not a possibility of being pregnant at the time of
enrollment or have a negative pregnancy test prior to initiation of radiation therapy

Exclusion Criteria:

- Multicentric breast cancer, defined as discontiguous tumors separated by at least 5 cm
of uninvolved tissue or discontiguous tumors that are located within separate breast
quadrants either clinical or mammographically.

- Multifocal breast cancer, defined as discontiguous discrete foci of invasive
carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5
cm, or within the same breast quadrant.

- Tumor > 2.0 cm, nodal involvement, or metastatic involvement

- Patients with either diffuse (>1 quadrant or > 5 cm) suspicious microcalcifications on
mammogram or diffuse non-mass-like enhancement on MRI

- History of ipsilateral cosmetic or reconstructive breast surgery

- Patients with a pacemaker or defibrillator

- Any contraindication to MRI including but not limited to the presence of a
pacemaker/defibrillator or other implanted ferromagnetic device or an inability to lie
prone

- Pregnant or lactating women

- Medical condition including but not limited to ongoing or active infection or
connective tissue disease (e.g. systemic sclerosis or other collagen vascular
diseases) that would, in the opinion of the treating physician, make this protocol
unreasonably hazardous to the patient.

- Psychiatric illness/social situation that would limit ability to provide informed
consent