A Randomized Phase III Study Comparing Docetaxel Followed by Cyclophosphamide, Epirubicin and 5-FU to Docetaxel With Capecitabine Followed by Cyclophosphamide, Epirubicin and Capecitabine as Adjuvant Treatment for Early Breast Cancer
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Heikki T Joensuu, M.D., prof.
Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland
Finland: Finnish Medicines Agency
FBCG Protocol No. 01-2003