A Study of Ramucirumab (IMC-1121B) in Participants With Breast Cancer
Condition: Breast Cancer; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Ramucirumab; Docetaxel
Intervention description: Ramucirumab administered as an intravenous (I.V.) infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks.; Docetaxel administered by intravenous (I.V.) infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.
Intervention MeSH terms: Docetaxel; Ramucirumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Female
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to investigate the safety and tolerability of the
      anti-VEGFR-2 monoclonal antibody ramucirumab drug product in combination with docetaxel in
      Japanese participants with metastatic, or locally advanced breast cancer, with the aim of
      confirming the recommended dose of ramucirumab drug product (DP) in combination with
      docetaxel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant is Japanese

          -  The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of
             0 or 1

          -  The participant has a histopathologically or cytologically confirmed diagnosis of
             breast adenocarcinoma that is now metastatic or locally-recurrent and inoperable with
             curative intent

          -  The participant has measurable and/or non-measurable disease

          -  The participants' primary and/or metastatic tumor is Human Epidermal Growth Factor
             Receptor 2 (HER2) negative

          -  The participant received neo adjuvant or adjuvant taxane therapy ≥ 6 months prior to
             the study

          -  The participant received neo adjuvant or adjuvant biologic therapy ≥ 6 weeks prior to
             the study

          -  The participant completed all prior radiotherapy ≥ 3 weeks prior to the study
             registration date

          -  The participant 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 participant's left ventricular ejection fraction (LVEF) is within normal ranges

          -  The participant has adequate hematologic, hepatic, and coagulation function.

          -  Eligible participants 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 participant has a concurrent active malignancy other than breast adenocarcinoma,
             adequately treated non-melanomatous skin cancer, or other non-invasive carcinoma or in
             situ neoplasm. Participants with previous treatment of malignancy is eligible,
             provided that she has been disease free for >3 years

          -  The participant has a known sensitivity to docetaxel

          -  The participant has a known sensitivity to agents of similar biologic composition as
             ramucirumab

          -  The participant has a history of chronic diarrheal disease within 6 months prior to
             the study registration date

          -  The participant has received irradiation to a major bone marrow area within 30 days
             prior to the study registration date

          -  The participant has received any experimental agents within 4 weeks prior to the study
             registration date

          -  The participant has a history of uncontrolled hereditary or acquired bleeding or
             thrombotic disorders

          -  The participant has Grade 3-4 bleeding within 3 months prior to the study registration
             date

          -  The participant has an ongoing or active infection requiring antibiotic, antifungal,
             or antiviral therapy

          -  The participant has uncontrolled hypertension, symptomatic congestive heart failure,
             psychiatric illness, or any other serious uncontrolled medical disorders

          -  The participant has brain metastases

          -  The participant has known human immunodeficiency virus infection or acquired
             immunodeficiency syndrome related illness

          -  The participant is pregnant or lactating

          -  The participant has not fully recovered from effects of prior chemotherapy

          -  The participant has undergone major surgery within 28 days prior to the study
             registration date