Prognostic and Predictive Impact of uPA/PAI-1

Breast Cancer Clinical Trial

— ChemoN0  

Official title:

Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317108
• Other study ID #: ChemoN0
• Secondary ID: GR280/4
• Status: Completed
• Phase: Phase 3
• First received: February 21, 2011
• Last updated: May 23, 2017
• Start date: June 1993
• Est. completion date: December 2008

Study information

• Verified date: March 2011
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 689
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• M1 status

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• CMF Chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Technische Universität München

References & Publications (1)

Jänicke F, Prechtl A, Thomssen C, Harbeck N, Meisner C, Untch M, Sweep CG, Selbmann HK, Graeff H, Schmitt M; German N0 Study Group.. Randomized adjuvant chemotherapy trial in high-risk, lymph node-negative breast cancer patients identified by urokinase-ty — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic impact of uPA/PAI-1: Number of patients disease-free in low vs. high risk groups according to uPA/PAI-1	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.	DFS at 3, 5, and 10 years (depending on analysis time point)
Primary	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	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.	DFS at 3, 5, and 10 years (depending on analysis time point)
Secondary	Overall survival	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.	at 3, 5, and 10 years (depending on analysis time point).