Clinical trial NCT01234402 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: capecitabine
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  The participant has histologically or cytologically confirmed breast cancer which at
             the time of study entry is either Stage III disease not amenable to curative therapy
             or Stage IV disease

          -  Has measurable or nonmeasurable disease

          -  Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Has received prior anthracycline therapy

          -  Has received prior taxane therapy

          -  Participants with human epidermal growth factor receptor-2 (HER2) positive disease
             must have progressed on or following trastuzumab

          -  Participants with hormone receptor-positive disease must have progressed on or
             following hormone therapy

          -  Has received ≤ 3 prior chemotherapy regimens in any setting (a regimen is defined as
             any agent[s] that has been administered for more than 1 cycle; sequential
             neoadjuvant/adjuvant treatment is considered 1 regimen)

          -  Has completed any prior radiotherapy ≥ 4 weeks prior to randomization

          -  Has completed any prior hormonal therapy ≥ 2 weeks prior to randomization

          -  Has adverse events (AEs) that have resolved to Grade ≤ 1 by the National Cancer
             Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v
             4.0) from all clinically significant toxic effects of prior chemotherapy, surgery,
             radiotherapy,or hormonal therapy

          -  Has adequate hematologic, coagulation, hepatic and renal function

          -  Does not have:

               -  cirrhosis at a level of Child-Pugh B (or worse) or

               -  cirrhosis (any degree) and a history of hepatic encephalopathy or ascites
                  resulting from cirrhosis and requiring ongoing treatment with diuretics and/or
                  paracentesis

          -  Has urinary protein is ≤ 1+ on dipstick or routine urinalysis; if urine protein ≥ 2+,
             a 24-hour urine collection must demonstrate < 1000 mg of protein in 24 hours to allow
             participation in the study

          -  Agrees to use adequate contraception during the study period and for 12 weeks after
             the last dose of study medication

        Exclusion Criteria:

          -  Has a concurrent active malignancy other than adequately treated nonmelanomatous skin
             cancer, curatively treated cervical carcinoma in situ, or other noninvasive carcinoma
             or in situ neoplasm. A participant with previous history of malignancy is eligible,
             provided that there has been a disease-free interval for > 3 years

          -  Has a known sensitivity to capecitabine, any of its components, or other drugs
             formulated with polysorbate 80

          -  Has a known sensitivity to 5-fluorouracil (5-FU)

          -  Has a known dihydropyrimidine dehydrogenase deficiency

          -  Has received prior capecitabine treatment for advanced breast cancer

          -  Has received investigational therapy within 2 weeks prior to randomization

          -  Has received bevacizumab within 4 weeks prior to randomization

          -  Has received more than 1 prior antiangiogenic agent for breast cancer

          -  Has a known sensitivity to agents of similar biologic composition as ramucirumab DP or
             Icrucumab (IMC-18F1), or other agents that specifically target vascular endothelial
             growth factor (VEGF)

          -  Has an acute/subacute bowel obstruction or history of chronic diarrhea requiring
             ongoing medical intervention

          -  Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders

          -  Has experienced a Grade ≥ 3 bleeding event within 3 months prior to randomization

          -  Is receiving prophylactic or therapeutic anticoagulation with warfarin or any other
             oral anticoagulant

          -  Has an uncontrolled intercurrent illness, including, but not limited to uncontrolled
             hypertension, symptomatic anemia, symptomatic congestive heart failure, unstable
             angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric
             illness/social situations, or any other serious uncontrolled medical disorder in the
             opinion of the investigator

          -  Has experienced any arterial thrombotic or thromboembolic events, including, but not
             limited to myocardial infarction, transient ischemic attack, or cerebrovascular
             accident within 6 months prior to randomization

          -  Has brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease

          -  Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or
             antiviral therapy

          -  Has received a prior allogeneic organ or tissue transplantation

          -  Has undergone major surgery within 4 weeks prior to randomization, or subcutaneous
             venous access device placement within 7 days prior to randomization

          -  Has had a serious nonhealing wound, ulcer, or bone fracture within 4 weeks prior to
             randomization

          -  Has known HIV or AIDS infection

          -  Has an elective or planned major surgery to be performed during the course of the
             trial

          -  Participant is pregnant or lactating