Prognostic and Predictive Impact of uPA/PAI-1

Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01317108

Acronym

ChemoN0

Enrollment

689

Registered

2011-03-17

Start date

1993-06-30

Completion date

2008-12-31

Last updated

2017-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

node-negative

Brief 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?

Interventions

DRUGCMF Chemotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* N0 breast cancer patients tumor size \>/= 1 and \</= 5 cm in diameter undergoing standard loco-regional treatment

Exclusion criteria

* M1 status

Design outcomes

Primary

Measure	Time frame	Description
Prognostic impact of uPA/PAI-1: Number of patients disease-free in low vs. high risk groups according to uPA/PAI-1	DFS at 3, 5, and 10 years (depending on analysis time point)	Interim analyses planned at 4.5, 6.5, and 8.5 years after first patient in. Final analysis scheduled at 10.5 years after last patient in.
The benefit of adjuvant chemotherapy in high-risk group according to uPA/PAI-1: Number of patients disease-free vs. those relapsed at the given time points	DFS at 3, 5, and 10 years (depending on analysis time point)	Interim analyses planned at 4.5, 6.5, and 8.5 years after first patient in. Final analysis scheduled at 10.5 years after last patient in.

Secondary

Measure	Time frame	Description
Overall survival	at 3, 5, and 10 years (depending on analysis time point).	Interim analyses planned at 4.5, 6.5, and 8.5 years after first patient in. Final analysis scheduled at 10.5 years after last patient in.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026