Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer

Inclusion Criteria

• Females >=18 years of age.
• Histologic diagnosis of HER2-negative breast cancer. HER-2 negativity must be confirmed by one of the following:
• FISH-negative (FISH ratio =3 weeks since last chemotherapy, and recovered from all acute toxicities, with the exception of alopecia.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2.
• Adequate organ function including the following:
• ANC >=1500 cells/mL
• Platelet count >=100,000 cells/mL
• Hemoglobin >=9 g/dL
• Total bilirubin =3 regimens of cytotoxic therapy in the advanced disease setting. (Any number of previous hormonal therapies are acceptable, as long as the therapy is discontinued prior to the patient's enrollment into this study).
• Major surgery or systemic therapy 25% of the bone marrow.
• Uncontrolled brain metastases. Patients with treated brain metastases (resection or radiotherapy) are eligible if brain metastases have responded to treatment as documented by CT or MRI scan obtained at >=2 weeks after completion of radiation therapy, neurologic symptoms are absent, and steroids have been discontinued.
• Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis.
• Diagnosis of second malignancy within the last 3 years (with the exception of carcinoma in situ of the cervix, squamous or basal cell skin cancer, thyroid cancer, ductal carcinoma in situ [DCIS], or lobular carcinoma in situ [LCIS]).
• Any of the following 7 days prior to the first dose of study treatment. The exception is radiotherapy for brain metastases, which must be completed >=21 days prior to study treatment. (Note: Any measurable lesion that has been previously irradiated will not be considered as a target lesion).
• Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
• History of seropositive HIV, or patients who are receiving immunosuppressive medications that increase the risk of neutropenic complications.
• Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
• Use of any non-approved or investigational agent <=30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.