A Phase II Trial of Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer

Inclusion Criteria:

- Females ≥ 18 years of age

- Histologically confirmed breast cancer that is HER2/neu positive (3+ by IHC or FISH
+) and evidence of metastatic disease. Tumor may be of any estrogen and progesterone
receptor type

- Measurable disease by RECIST and an ECOG ≤ 2

- Patients with known evidence of brain metastases are eligible if they are
asymptomatic and have completed all therapy (surgery, radiotherapy, and/or steroids)

- Baseline LVEF value within the institutional normal range

- Any number of prior hormonal therapy treatments in the adjuvant setting or for
metastatic disease. A subject must have progressed on hormonal therapy and all
hormonal therapy (including birth control pills) must be discontinued at study entry.

- Prior chemotherapy in the adjuvant setting and up to one prior chemotherapy regimen
for metastatic disease is allowed.

- Patients may have received one prior trastuzumab/chemotherapy containing regimen or
prior single agent trastuzumab.

- Prior radiation therapy in the adjuvant setting or for metastatic disease, provided
it was not to the only site of evaluable disease.

- All prior chemotherapy, trastuzumab and radiation therapy should be completed > 2
weeks before enrollment.

- Patients receiving bisphosphonate therapy are eligible. However, if bisphosphonate
were started within < 2 months prior to enrollment, the bone lesions will not be
evaluated for response and the patient must have another site of metastatic disease
that is either measurable or evaluable for response.

- Patients must have recovered from toxicities due to prior therapy.

- Lab values in accordance with the protocol

- Patients must be nonpregnant and nonlactating. Patients of childbearing potential
must implement an effective method of contraception during the study (birth control
pills are not allowed).

Exclusion Criteria:

- Bone only disease are ineligible

- Patients who received more than 1 prior chemotherapy regimen for metastatic disease
are ineligible.

- Patients with a history of other cancers except curatively-treated carcinoma of the
cervix in situ or non-melanomatous skin cancer.

- Active serious infection or other underlying medical condition that would impair
their ability to receive protocol treatment.

- Uncontrolled nervous system metastases

- Dementia or significantly altered mental status that would interfere with proper
consenting.

- Receiving other investigational therapy.