Statement: the secondary trial is testing for the DLT of its interventions, whereas the primary trial is evaluating the dose limiting toxicity for SentiMag and SiennaXP. 
Primary_evidence: Outcome Measurement:    Number of Participants With Detected Lymph Nodes   The proportion of lymph nodes detected intraoperatively by SentiMag and SiennaXP in relation the proportion of lymph nodes detected by the combination of Technetium Sulfur Colloid and Isosulfan blue dye   Time frame: During surgical procedure <1 hour Results 1:    Arm/Group Title: SiennaXP Injection   Arm/Group Description: Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye.   Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.   SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe   Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid) Isosulfan blue dye: Injection of a single dose of isosulfan blue dye   Overall Number of Participants Analyzed: 146   Measure Type: Count of Participants   Unit of Measure: Participants  145  99.3%
Secondary_evidence: Outcome Measurement:    Number of Participants With Dose Limiting Toxicity (DLT)   For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.   Time frame: Up to 3 weeks Results 1:    Arm/Group Title: E7389 With Weekly Trastuzumab   Arm/Group Description: Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.   Overall Number of Participants Analyzed: 6   Measure Type: Number   Unit of Measure: Participants  0 Results 2:    Arm/Group Title: E7389 With Tri-weekly Trastuzumab   Arm/Group Description: Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.   Overall Number of Participants Analyzed: 6   Measure Type: Number   Unit of Measure: Participants  0