Capecitabine in Women With Operable Breast Cancer

- Prior to the start of treatment, patients will have a small metal clip inserted into
the tumor bed to identify the tumor site to the surgeon. At that time, a needle biopsy
of the breast tumor or a sentinel (underarm) lymph node biopsy will also be performed.

- Patients will take capecitabine orally twice daily for 14 days. This treatment will
repeat every 21 days (1 cycle). Patients will receive 4 cycles of this treatment.

- A physical exam and blood work will be done every three weeks after starting therapy to
monitor side effects.

- After two weeks of capecitabine a biopsy from the tumor will be done to generate
information about the characteristics of the tumor that may respond to capecitabine.

- After completing 4 cycles (12 weeks) of capecitabine, patients will then undergo
surgery to remove any remaining breast cancer (lumpectomy or mastectomy). Post-surgical
treatment (radiation, chemotherapy, and hormonal therapy) is at the discretion of the
patients physician.

Inclusion Criteria:

- Histological confirmation of primary invasive breast cancer

- Stage I-III operable breast cancer.

- Primary tumor must be greater than or equal to 2cm by radiographic imaging or
palpitation

- Women greater than 18 years of age

- ECOG performance status 0-1

- WBC > 4000/mm3

- Platelet count > 100,000/mm3

- SGOT < 2x ULN

- Calculated creatinine clearance > 50ml/min

Exclusion Criteria:

- Evidence of metastatic (stage IV) cancer on physical exam or any diagnostic study.

- Pregnant or breast-feeding women

- Inflammatory breast cancer

- HER2 positive disease

- History of hypersensitivity to a 5-FU or known dihydropyrimidine dehydrogenase (DPD)
deficiency

- Uncontrolled intercurrent illness

- Prior history of breast cancer are ineligible except: diagnosed at least 2 years ago;
present cancer is not in previously irradiated breast; no prior chemotherapy in the
past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow
transplant.

- Excisional biopsy performed prior to enrollment

- Uncontrolled coagulopathy

- Lack of physical integrity of the upper gastrointestinal tract or malabsorption
syndrome.