Although the management of breast cancer has improved over the past fe
w decades, it remains an important challenge for the clinician. Cytoto
xic chemotherapy and hormonotherapy, when given in the adjuvant settin
g, have a definitive though modest impact on the outcome of early-stag
e breast cancer. In metastatic disease, these therapies help to provid
e substantial palliation of symptoms but have a limited impact on surv
ival. The discovery of vinorelbine and the taxanes, paclitaxel and doc
etaxel, certainly represented the most encouraging clinical developmen
t of the 1980s in breast cancer therapy. Several other new cytotoxic a
gents have been recognised for their potential in the treatment of thi
s disorder. Many of them are only in a very early phase of their clini
cal development and it remains to be proven that they will have a majo
r role in daily practice in the near future. In terms of hormonal trea
tment, new aromatase inhibitors and new antiestrogens have been develo
ped and, to date, show equivalent efficacy compared with the more clas
sical hormonal agents. Some of them may be substantially better tolera
ted. Our increasing understanding of the process of metastasis, of the
mechanisms of resistance of cancer cells and of cell transformation,
proliferation and differentiation is now translating into several prom
ising new treatment strategies for the management of breast cancer pat
ients. Thus, the success of these promising new therapeutic agents and
strategies, which have been identified over the past few years and ar
e in various stages of clinical development, will certainly depend in
part on their proper evaluation in well designed clinical trials.