Docetaxel Followed by CEF (Cyclophosphamide, Epirubicin and 5-Fluorouracil) Compared to Docetaxel and Capecitabine Followed by CEX (Cyclophosphamide, Epirubicin and Capecitabine) as Adjuvant Treatment for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study compares two chemotherapy regimens as adjuvant treatment for breast cancer. The
      study participants are randomly allocated to receive either 3 cycles of docetaxel followed by
      3 cycles of CEF (cyclophosphamide, epirubicin and 5-fluorouracil) or to receive 3 cycles of
      docetaxel plus capecitabine followed by 3 cycles of CEX (cyclophosphamide, epirubicin and
      capecitabine). The study participants are required to to have a medium to high risk for
      breast cancer recurrence. The primary aim of the study is to investigate whether addition of
      capecitabine to a standard taxane/anthracycline regimen will influence recurrence-free
      survival.
    

Detailed description: 
      This is an open-label, two-arm, randomized multi-center phase III trial to compare efficacy
      and safety of a taxane-anthracycline regimen to a taxane-anthracycline-capecitabine regimen
      as adjuvant treatment of early breast cancer with an intermediate-to-high risk of cancer
      recurrence.

      Patients diagnosed with early breast cancer with an estimated risk of 25% or greater for
      distant recurrence within 5 years from the diagnosis will be randomly allocated to one of the
      following 2 arms (1:1):

        -  Arm A -- 3 cycles of docetaxel 80 mg/m² intravenous (i.v.) (repeated on day [d.] 22);
           followed by 3 cycles of CEF (cyclophosphamide 600 mg/m2 i.v., epirubicin 75mg/m² i.v.,
           5-fluorouracil 600 mg/m2 i.v., repeated on d. 22)

        -  Arm B -- 3 cycles of TX (docetaxel 60 mg/m² i.v., capecitabine twice daily 900 mg/m²
           given orally on days 1-15 of the cycle; cycle repeated on d. 22); followed by 3 cycles
           of CEX (cyclophosphamide 600 mg/m2 i.v., epirubicin 75mg/m² i.v, capecitabine twice
           daily 900 mg/m² on days 1-15 of the cycle; cycle repeated on d. 22)

      Locoregional radiotherapy is given according to the institutional practice after completing
      adjuvant chemotherapy (Tx3/CEFx3 or TXx3/CEXx3).

      All patients with ER and/or PgR positive disease will receive adjuvant endocrine therapy.
      This will consist of 1 mg p.o. anastrozole (ArimidexR) given for 60 months in women who were
      post-menopausal prior to chemotherapy (no menstrual periods for > 6 months) or of tamoxifen
      20 mg p.o. for 60 months in women who were pre-menopausal prior to chemotherapy.

      Use of trastuzumab is allowed in HER-2 positive disease.

      Patients will be followed up for 5 years post-randomization.
    

Intervention name(s): capecitabine; docetaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Docetaxel; Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; chemotherapy; adjuvant; capecitabine; docetaxel