Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer

Combination Study of LY188011 and Paclitaxel in Patients With Metastatic/Recurrent Breast Cancer After Neo-adjuvant/Adjuvant Chemotherapy With Anthracycline

To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen

Inclusion Criteria:

• Histologically and/or cytologically confirmed breast cancer
• Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen
• To have at least one measurable region
• Eastern Cooperative Oncology Group (ECOG) Performance Status: 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 breast cancer
• Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
• To have brain metastases with symptoms
• To have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)