Prognostic and Predictive Impact of uPA/PAI-1 (ChemoN0)

• ClinicalTrials.gov Identifier: NCT01317108
• Recruitment Status: Completed
• First Posted: March 17, 2011
• Last Update Posted: May 25, 2017
• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborator: Technical University of Munich
• Information provided by (Responsible Party): Universitätsklinikum Hamburg-Eppendorf

Study Description

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?

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: CMF Chemotherapy	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 689 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0
• Study Start Date: June 1993
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
No Intervention: A; Low uPA/PAI-1: Observation
No Intervention: B2; High uPA/PAI-1: Observation
No Intervention: B3; High uPA/PAI-1: refused randomization
Active Comparator: B1; High uPA/PAi-1: CMF chemotherapy	Drug: CMF Chemotherapy

Outcome Measures

Primary Outcome Measures :

1. Prognostic impact of uPA/PAI-1: Number of patients disease-free in low vs. high risk groups according to uPA/PAI-1 [ Time Frame: 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.
2. 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 [ Time Frame: 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 :

1. Overall survival [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• M1 status

Contacts and Locations

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Technical University of Munich

Investigators

• Principal Investigator: Fritz Jaenicke, MD; Universitätsklinikum Hamburg-Eppendorf

More Information

Publications of Results:

Janicke 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-type plasminogen activator and plasminogen activator inhibitor type 1. J Natl Cancer Inst. 2001 Jun 20;93(12):913-20. doi: 10.1093/jnci/93.12.913.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Harbeck N, Schmitt M, Meisner C, Friedel C, Untch M, Schmidt M, Sweep CG, Lisboa BW, Lux MP, Beck T, Hasmuller S, Kiechle M, Janicke F, Thomssen C; Chemo-N 0 Study Group. Ten-year analysis of the prospective multicentre Chemo-N0 trial validates American Society of Clinical Oncology (ASCO)-recommended biomarkers uPA and PAI-1 for therapy decision making in node-negative breast cancer patients. Eur J Cancer. 2013 May;49(8):1825-35. doi: 10.1016/j.ejca.2013.01.007. Epub 2013 Mar 13.

• Responsible Party: Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT01317108
• Other Study ID Numbers: ChemoN0; GR280/4 ( Other Grant/Funding Number: German Research Association )
• First Posted: March 17, 2011
• Last Update Posted: May 25, 2017
• Last Verified: March 2011

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:

node-negative

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases