Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen

A Multicenter Study of LY188011 in Anthracyclines and Taxanes Pre-treated Metastatic/Recurrent Breast Cancer

To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with metastatic breast cancer

Inclusion Criteria:

• Histologically and/or cytologically confirmed breast cancer
• Received prior chemotherapy for metastatic breast cancer with anthracycline and taxane regimen
• To have at least one measurable region
• PS: 0-1
• To have adequate organ function (bone marrow, liver and renal function)

Exclusion Criteria:

• To have Interstitial pneumonia or pulmonary fibrosis
• To have inflammatory carcinoma
• Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
• To have brain metastasis with symptom
• To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)