A Phase 2 Trial of Amrubicin With or Without Herceptin in the Treatment of Metastatic Breast Cancer

Inclusion Criteria:

- Histological or cytological diagnosis of breast cancer.

- Metastatic or recurrent disease, either HER2+ (FISH+ or 3+ IHC) or HER2-.

- Maximal dose of prior adjuvant anthracycline: 300 mg/meters squared doxorubicin or
equivalent. Relapse greater than one year after trastuzumab adjuvantly; two years
following adjuvant anthracycline therapy (without trastuzumab).

- One prior chemotherapy for metastatic breast cancer allowed (may include trastuzumab
for HER2+ patients), but no prior Doxil, adriamycin or epirubicin for metastatic
breast cancer.

- At least 18 years of age.

- ECOG Performance Status of 0, 1, or 2.

- Adequate organ function including the following:

- Adequate bone marrow reserve.

- Cardiac: Left ventricular ejection fraction (LVEF) greater than or equal to 55%
by MUGA.

- Negative serum pregnancy test at the time of enrollment for women of child-bearing
potential.

- Ability to understand the requirements of the study, provide written informed consent
and authorization of use and disclosure of protected health information, and agree to
abide by the study restrictions and to return for the required assessments.

Exclusion Criteria:

- Pregnant or nursing women.

- Concurrent anticancer therapy.

- Participation in any investigational drug study within 28 days prior to study entry.

- Concurrent severe or uncontrolled medical disease (i.e., active systemic infection,
diabetes, uncontrolled hypertension, coronary artery disease, congestive heart
failure, severe arrhythmia) that, in the opinion of the Investigator, would
compromise the safety of the patient or compromise the ability of the patient to
complete the study.

- Symptomatic central nervous system metastases. Patients with asymptomatic brain
metastases are allowed. The patient must be stable after radiotherapy for greater
than or equal to 2 weeks and off corticosteroids for greater than or equal to 1 week.

- History of interstitial lung disease or pulmonary fibrosis.