Statement: the conclusions drawn from the primary clinical trial and secondary clinical trial are not equivalent or comparable.
Primary_evidence: Outcome Measurement:    Number of Participants With Complete Pathologic Response.   Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR.   Although clinical examination is the primary method of determining response, radiologic assessments (mammogram, ultrasound ± MRI) may be used to confirm response/non-response.   Time frame: assess at 8 weeks Results 1:    Arm/Group Title: Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine   Arm/Group Description: Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta  ) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.   Overall Number of Participants Analyzed: 27   Measure Type: Number   Unit of Measure: participants  13
Secondary_evidence: Outcome Measurement:    Change in Masood Score   Change in the semi-quantitative score assigned by the designated cytopathologist.   Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4.   Time frame: Baseline to 6 months Results 1:    Arm/Group Title: Placebo   Arm/Group Description: Placebo   Placebo: matched tablet dialy   Overall Number of Participants Analyzed: 84   Mean (Standard Deviation)   Unit of Measure: units on a scale  -1.1         (1.9) Results 2:    Arm/Group Title: Arzoxifene   Arm/Group Description: LY353381, 20 mg daily   arzoxifene: one tablet daily   Overall Number of Participants Analyzed: 82   Mean (Standard Deviation)   Unit of Measure: units on a scale  -0.8         (2.1)