Phase II Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer

Inclusion Criteria:

- Histologically proven dx of recurrent or metastatic breast cancer

- Must have received at least 1 but not more than 3 prior chemotherapy regimens
for recurrent or metastatic breast cancer. Patients who relapse within 12 months of
completing adjuvant chemotherapy can only have had up to 2 prior regimens for
metastatic disease. Patients who relapse within 12 months of completing adjuvant
chemotherapy containing an anthracycline and a taxane, do not require prior
chemotherapy for metastatic disease.

- Unidimensionally measurable dz (by RECIST)

- At least 18 yrs of age

- SWOG PS 0-2

- AGC greater than or equal to 1.5; platelets greater than or equal to 100,000; Hgb
greater than or equal to 8.0

- Total bilirubin less than or equal to 2 x uln; SGOT and/or SGPT and alk phos up to
2.5 x uln

- Creatinine less than or equal to 2.0

- Fully recovered from acute toxicities secondary to prior tx

- Signed informed consent (including HIPAA authorization)

- Peripheral neuropathy grade 0-1

Exclusion Criteria

- Prior tx with gemcitabine or oxaliplatin. Prior tx with cisplatin or carboplatin
allowed if completed >12 mos prior to enrollment.

- Underlying medical, psychiatric, or social conditions that would preclude patient
from receiving tx

- Peripheral neuropathy greater than or equal to Gr 2

Exclusion Criteria:

-