Preoperative Epirubicin Paclitaxel Aranesp Study (PREPARE)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The present clinical trial will investigate the efficacy of a sequential interval-shortened
      and dose-intensified preoperative use of epirubicin, paclitaxel and CMF with preoperative
      sequential administration of epirubicin and cyclophosphamide followed by paclitaxel in breast
      cancer. In addition, the influence of darbepoetin alfa on the response rate and quality of
      life is to be investigated in both treatment arms.
    

Detailed description: 
      Arm A: Sequential treatment in standard doses with Epirubicin (90 mg/m2)/cyclophosphamide
      (600 mg/m2) d1, q21d - 4× followed by paclitaxel (175 mg/m2) d1, q21d - 4×.

      Pegfilgratim should be used as secondary preventive after febrile neutropenia in the standard
      arm of the study, or in exceptional cases also after severe febrile neutropenia necessitating
      postponement of the treatment by more than one week ± Darbepoetin alfa 1 × 4.5 µg/kg of body
      weight every two weeks with the start of the first epirubicin dose (day 1) until 14 days
      after the last dose of paclitaxel Daily oral intake of 200 mg iron unless there complications
      occur with taking iron

      Arm B: sequential dose-intensified, interval-shortened treatment with Epirubicin (150 mg/m2)
      d1, q14d - 3× followed by paclitaxel (225 mg/m2) d1, q14d - 3×, followed by CMF (600/40/600
      mg/m2) d1/d8, q28d - 3× Obligatory pegfilgratim 6 mg after epirubicin and/or paclitaxel:
      subcutaneous injection on day 2. After CMF pegfilgrastim should be used as a secondary
      preventive measure

      ± Darbepoetin alfa 1 × 4.5 µg/kg of body weight every two weeks with the start of the first
      dose of epirubicin (day 1) until 14 days after the last dose of CMF Daily oral dose of 200 mg
      iron unless complications occur in taking iron.

      Primary goal: Determining the relapse-free survival time and overall survival after
      dose-intensified sequential preoperative chemotherapy including anthracycline and taxan
      and/or after preoperative chemotherapy including anthracycline followed by taxan in a
      standard dose
    

Intervention name(s): Epirubicin, paclitaxel, cyclophosphamide, Methotrexate, 5 FU, darbepoetin alfa; Epirubicin, Cyclophosphamide, Paclitaxel, dabepoetin alfa
Intervention type(s): Drug; Drug
Intervention description(s): Epirubicin (90 mg/m2) d1, q21d - 4× / cyclophosphamide (600 mg/m2) d1, q21d - 4× followed by paclitaxel (175 mg/m2) d1, q21d - 4×
+/- Darbepoetin alfa 1 × 4.5 μg/kg of body weight every two weeks with the start of the first epirubicin dose (day 1) to 14 days after the last dose of paclitaxel; Epirubicin (150 mg/m2) d1, q14d - 3× followed by paclitaxel (225 mg/m2) d1, q14d - 3×, followed by CMF d1/d8, q28d - 3× Obligatory pegfilgratim 6 mg, subcutaneous injection on day 2 after epirubicin and/or paclitaxel and secondary prophylactic dose after CMF
+/- Darbepoetin alfa 1 × 4.5 μg/kg of body weight every two weeks with the start of the first dose of epirubicin (day 1) until 14 days after the last dose of CMF
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Cyclophosphamide; Methotrexate; Epirubicin; Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; neoadjuvant therapy; pCR rates