Chemo-N0 (1993-1998) is the first prospective randomized multicenter trial in N0 BC designed
to prospectively evaluate the clinical utility of a biomarker. It used uPA/PAI 1 as
stratification criteria and randomized high-risk patients to chemotherapy versus observation;
low-risk patients remained without any systemic therapy. The trial was designed to answer two
principle questions:
1. Can the reported prognostic impact of uPA and PAI 1 be validated in a prospective
multicenter therapy trial? Does low uPA/PAI 1 identify those low-risk N0 patients who
are candidates for being spared necessity and burden of adjuvant chemotherapy?
2. Do uPA/PAI 1 high-risk patients benefit from adjuvant CMF chemotherapy?