Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients

Eligibility Criteria

Subjects must:

- be ≥ age 18 years of age with a documented pathological diagnosis of Stage Ia (T1,
N0, M0), Stage Ib (T0 or 1, N1mic, M0) or Stage IIa (T<3cm, N0, M0) infiltrating
ductal or lobular carcinoma of the breast or ductal carcinoma in situ (DCIS).

- be post-surgical patients scheduled to be treated with at least 40 to 50.4 Gy to the
whole breast and axilla using either standard or hypofractionated radiation
techniques . An additional 10-16 Gy boost to the lumpectomy region may also be
delivered. All radiation treatment is to be delivered based on standard CT planning.

- have the ability to understand the informed consent document.

- be able to comply with protocol schedule.

- have a negative serum pregnancy test (within 7 days prior to starting radiation
therapy), if a female of child bearing potential.

- consent to utilize medically acceptable methods of contraception throughout the study
period if of child-bearing potential.

Exclusion Criteria

Subjects:

- with unhealed surgical wounds or scars in the study treatment area (axilla).

- with underlying active untreated cardiac disease (e.g. arrhythmia).

- with generalized skin disorders that have required treatment within the past 6
months.

- with connective tissue disorders.

- with rashes, ulcerations, or poorly healed scars in the study drug application area
(axilla).

- with a known allergy to norepinephrine.

- with known uncontrolled hypertension (repeatedly elevated BP; systolic BP >139 or
diastolic BP >89).

- with a known clinically significant abnormal ECG within the past 6 months.

- receiving MAO inhibitors or antidepressants (triptyline or imipramine types).

- who are pregnant or breastfeeding.

- with lymphovascular space invasion on pathology.

- with dermal lymphatic invasion on pathology.

- with proximity of the tumor to the overlying skin as evidenced by a distance of less
than 5 mm on US or MRI (if performed) and within 2 cm of the anticipated application
field

- diagnosis of inflammatory breast cancer.

- receiving chemotherapy other than Herceptin concurrent with the radiation.

- with previous radiation to the breast to be treated.