Statement: All cohorts in the primary trial had lower percentage of participants with pCR compared to cohort 1 of the secondary trial.
Primary_evidence: Outcome Measurement:    Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D).   Within 3-4 weeks after last docetaxel dose the surgery was performed to evaluate pathological response. According to the Miller&Payne Criteria, pCR in node-negative patients is a grade 5-A and in node-positive patients is a grade 5-D.   Time frame: Up to 16 weeks Results 1:    Arm/Group Title: Arm 1: EC -> D + Lapatinib   Arm/Group Description: EC -> D + Lapatinib   Drugs plus Biological   Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + lapatinib each 21 days for 4 cycles)   Overall Number of Participants Analyzed: 51   Measure Type: Number   Unit of Measure: percentage of participants with pCR  23.5        (11.9 to 35.1) Results 2:    Arm/Group Title: Arm 2: EC -> D + Trastuzumab   Arm/Group Description: EC -> D + Trastuzumab   Drug plus Biological   Epirubicin + Cyclophosphamide (EC) each 21 days for 4 cycles -> Docetaxel (D) + Trastuzumab each 21 days for 4 cycles   Overall Number of Participants Analyzed: 48   Measure Type: Number   Unit of Measure: percentage of participants with pCR  47.9        (33.8 to 62.0)
Secondary_evidence: Outcome Measurement:    Number of Patients With a Pathological Complete Response (pCR) Who Received Targeted Therapy With Trastuzumab and Pertuzumab or Bevacizumab Predicted by Genomically-derived Molecular Subtypes.   Number of patients with a pathological complete response (pCR) who received targeted therapy with trastuzumab and pertuzumab or bevacizumab predicted by genomically-derived molecular subtypes (HER2 positive or HER2 negative. pCR is defined as absence of invasive cancer in breast or lymph nodes after neoadjuvant chemotherapy.   Time frame: Up to 30 days after last cycle of treatment Results 1:    Arm/Group Title: Cohort 1P (HER2 Positive)   Arm/Group Description: Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.   Overall Number of Participants Analyzed: 5   Measure Type: Count of Participants   Unit of Measure: Participants  4  80.0% Results 2:    Arm/Group Title: Cohort 1T (HER2 Positive)   Arm/Group Description: Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.   Overall Number of Participants Analyzed: 6   Measure Type: Count of Participants   Unit of Measure: Participants  6 100.0%