A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)

• Biological: PF-05280014
  
  Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum of 6 cycles.
• Drug: Taxotere®
  
  Injection concentrate single-dose vials containing 20 mg (0.5 mL) or 80 mg (2 mL), each mL contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80, The starting dose of Taxotere® (docetaxel) will be 75 mg/m2 administered intravenously over 60 minutes every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
  Other Name: docetaxel
• Drug: Paraplatin®
  
  Lyophilized powder, single-dose vials containing 50 mg, 150 mg, and 450 mg of Carboplatin for administration by intravenous infusion (each vial contains equal parts by weight of Carboplatin and mannitol), starting dose 6 AUC, over 15 minutes or longer every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
  Other Name: carboplatin
• Biological: Trastuzumab-EU
  
  Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum 6 cycles.

• Experimental: PF-05280014
  
  Interventions:
  

  • Biological: PF-05280014
  • Drug: Taxotere®
  • Drug: Paraplatin®
• Active Comparator: Herceptin®
  
  Interventions:
  

  • Biological: Trastuzumab-EU
  • Drug: Taxotere®
  • Drug: Paraplatin®

Inclusion Criteria:

• Histologically confirmed HER2 overexpressing invasive breast cancer.
• Plan for definitive surgical resection of breast tumor (i.e., lumpectomy or mastectomy, and sentinel node (SN) biopsy or axillary lymph node dissection (ALND).
• Plan for neoadjuvant chemotherapy.
• Measurable disease in the breast after diagnostic biopsy, defined as longest diameter ? 2.0 cm.

Exclusion Criteria:

• Bilateral breast cancer.
• Inflammatory breast cancer.
• Presence of known distant metastases.
• Received prior treatment, including chemotherapy, endocrine therapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer.