Study of 0.1% Uracil Ointment (1UO) Ointment for the Prevention of Hand-Foot Syndrome

Capecitabine is used in the treatment of human breast cancer among other human cancers.
Following absorption, capecitabine is converted enzymatically to 5-fluorouracil (5-FU). The
administration of capecitabine or 5-FU can cause a cutaneous toxicity known as hand-foot
syndrome (HFS) or palmar-plantar erythrodysesthesia (PPE). HFS is progressive with dose and
duration of exposure to 5-FU or capecitabine. HFS is characterized by progressive redness
and cracking of hands and feet. Currently, there are no approved therapies for HFS.

Inclusion Criteria:

- Females, at least 18 years old

- Histologically or cytologically confirmed metastatic breast cancer

- You also cannot have any ulcerations or open wounds on palms of hands or soles of
feet

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for
nitrosoureas or mitomycin C)prior to entering the study or if you have not recovered
to Grade 1 or better (except for alopecia)from adverse events due to agents
administered more than 2 weeks earlier.

- Use vitamin 6, chronic use of Cox-2 inhibitors, use full-dose anti- coagulants or use
nicotine patches.

The above is not a complete list of eligibility criteria. Please see your study doctor for
more information.