Statement: Participants in the primary trial had a higher likelihood of achieving 2 Year Disease-Free Survival than those in either cohort of the secondary trial.
Primary_evidence: Outcome Measurement:    Tumor Response Rate (Complete and Partial) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)   [Not Specified]   Time frame: 4 weeks Results 1:    Arm/Group Title: Arm 1   Arm/Group Description: Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.   lapatinib ditosylate: Given orally   tamoxifen citrate: Given orally   Overall Number of Participants Analyzed: 17   Measure Type: Number   Unit of Measure: participants  1        (1 to 27)
Secondary_evidence: Outcome Measurement:    Percentage of Patients With a 2 Year Disease-Free Survival (DFS) as a Measure of Efficacy   The percentage of patients that are without evidence of disease recurrence at the 2 year timepoint, as measured from date of first protocol treatment date to first documented disease progression date or date of death from any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.   Time frame: Up to 2 years Results 1:    Arm/Group Title: Cohort A: Triple-negative Breast Cancer Patients   Arm/Group Description: Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.   Overall Number of Participants Analyzed: 53   Measure Type: Number   Unit of Measure: percentage of patients  56        (42 to 69) Results 2:    Arm/Group Title: Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients   Arm/Group Description: Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.   Overall Number of Participants Analyzed: 42   Measure Type: Number   Unit of Measure: percentage of patients  83        (67 to 91)