Overview

Prognostic and Predictive Impact of uPA/PAI-1

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
Female
Summary
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?
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborator:
Technische Universität München
Criteria
Inclusion Criteria:

- N0 breast cancer patients tumor size >/= 1 and standard loco-regional treatment

Exclusion Criteria:

- M1 status