Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy

Inclusion Criteria:

- Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted)

- Patient has undergone mastectomy with tissue expander-based reconstruction and require
post-mastectomy radiation therapy (PMRT) per the - Stage DCIS (0) -III breast cancer,
excluding any patients with inflammatory breast cancer at presentation.

- Patient will receive irradiation of the chest wall. Additional fields to treat the
regional nodes including the supraclavicular / axillary and/or internal mammary chains
is allowed but not required. If a patient requires a boost field to the chest wall,
scar and/or nodal region this is allowed.

Exclusion Criteria:

- Patient with skin changes or inflammatory carcinoma at presentation Patient has
(cT4b-d)

- unhealed wound in the radiation field

- Patient has allergy to Caffeine

- Patient has systemic lupus erythematosus or scleroderma that increases the risk of
radiation dermatitis development

- Patient will receive concurrent chemotherapy with radiation. (Patient is allowed to
take concurrent hormonal therapy or Trastuzumab)

- Planned accelerated or hypofractionated fractionation.

- Previous radiation to the ipsilateral breast or chest wall or thoracic region.

- Anyone who will require bolus use during radiation (per physician discretion) as this
will increase rates of acute toxicity interfering with measurement of the primary
study endpoint.

- All pre-menopausal women will require a urine qualitative pregnancy test to exclude
pregnancy. Pregnant women will be excluded from the study.