A Study of Ramucirumab (IMC-1121B) in Patients With Breast Cancer

Inclusion Criteria:

• The patient is Japanese
• The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• The patient has a histopathologically or cytologically confirmed diagnosis of breast adenocarcinoma that is now metastatic or locally-recurrent and inoperable with curative intent
• The patient has measurable and/or non-measurable disease
• The patients' primary and/or metastatic tumor is HER2-negative
• The patient received neo adjuvant or adjuvant taxane therapy ≥ 6 months prior to the study
• The patient received neo adjuvant or adjuvant biologic therapy ≥ 6 weeks prior to the study
• The patient completed all prior radiotherapy ≥ 3 weeks prior to the study registration date
• The patient received prior hormonal therapy for breast cancer in the neo adjuvant, adjuvant,and/or the metastatic setting ≥ 2 weeks prior to the study registration date
• The patient's left ventricular ejection fraction (LVEF) is within normal ranges
• The patient has adequate hematologic, hepatic, and coagulation function.
• Eligible patients of reproductive potential agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for 12 weeks after the last dose of study medication

Exclusion Criteria:

• The patient has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non-melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm
• The patient has a known sensitivity to docetaxel
• The patient has a known sensitivity to agents of similar biologic composition as ramucirumab
• The patient has a history of chronic diarrheal disease within 6 months prior to the study registration date
• The patient has received irradiation to a major bone marrow area within 30 days prior to the study registration date
• The patient has received any experimental agents within 4 weeks prior to the study registration date
• The patient has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
• The patient has Grade 3-4 bleeding within 3 months prior to the study registration date
• The patient has an ongoing or active infection requiring antibiotic, antifungal, or antiviral therapy
• The patient has uncontrolled hypertension, symptomatic congestive heart failure, psychiatric illness, or any other serious uncontrolled medical disorders
• The patient has brain metastases
• The patient has known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness
• The patient is pregnant or lactating
• The patient has not fully recovered from effects of prior chemotherapy
• The patient has undergone major surgery within 28 days prior to the study registration date