Statement: the secondary trial and the primary trial do not have comparable Outcome Measurements.
Primary_evidence: Outcome Measurement:    Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0)   DLTs as per NCI CTCAE v3.0 were defined as:1) Neutropenia Grade 4 that lasted at least 7 days, 2) Neutropenia Grade 3 or 4 complicated by fever and/or infection (absolute neutrophil count [ANC] less than 1.0*10^9/liter [L], fever of at least 38.5 degree celsius [°C]), 3)Thrombocytopenia Grade 4, 4) Thrombocytopenia Grade 3 complicated by bleeding and/or requiring platelet or blood transfusion, 5) Non-hematological toxicity Grade 3 or higher (excluding Grade 3 nausea, and Grade 3 or 4 vomiting or diarrhea in participants who had not received optimal treatment with antiemetic and/or antidiarrheal medication; excluding laboratory abnormalities without clinical symptoms), 6) Delayed recovery from treatment-related toxicity resulting in dose delay greater than 14 days, 7) Failure to administer at least 75 percent (%) of planned study drugs during Cycle 1 as result of Grade 2 or higher treatment-related toxicity that constituted increase of at least 2 grades from baseline.   Time frame: Cycle 1 (21 days) Results 1:    Arm/Group Title: Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)   Arm/Group Description: Participants received eribulin mesilate 1.2 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).   Overall Number of Participants Analyzed: 8   Measure Type: Count of Participants   Unit of Measure: Participants  1  12.5% Results 2:    Arm/Group Title: Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)   Arm/Group Description: Participants received eribulin mesilate 1.6 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).   Overall Number of Participants Analyzed: 6   Measure Type: Count of Participants   Unit of Measure: Participants  1  16.7%
Secondary_evidence: Outcome Measurement:    Concordance of Blue Dye and Lymphoseek   The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.   Time frame: Surgery after injections of Lymphoseek and blue dye Results 1:    Arm/Group Title: Intent-To-Treat   Arm/Group Description: Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.   Overall Number of Participants Analyzed: 133   Overall Number of Units Analyzed   Type of Units Analyzed: Lymph Nodes  Measure Type: NumberNumber (95% Confidence Interval)Unit of Measure: Proportion of Lymph Nodes: 1.0000        (0.9840 to 1.0000)