Prognostic and Predictive Impact of uPA/PAI-1

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: CMF Chemotherapy

• Registration Number: NCT01317108
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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?

Detailed Description

Not available

Study Timeline

• Study Start: 1993-06
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2011-02-21
• Status Verified: 2011-03
• Study First Submitted QC: 2011-03-15
• Study First Posted: 2011-03-17
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 689

Inclusion Criteria

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

Exclusion Criteria

• M1 status

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B1	CMF Chemotherapy	High uPA/PAi-1: CMF chemotherapy

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.