Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
689 participants
INTERVENTIONAL
1993-06-30
2008-12-31
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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A
Low uPA/PAI-1: Observation
No interventions assigned to this group
B2
High uPA/PAI-1: Observation
No interventions assigned to this group
B3
High uPA/PAI-1: refused randomization
No interventions assigned to this group
B1
High uPA/PAi-1: CMF chemotherapy
CMF Chemotherapy
Interventions
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CMF Chemotherapy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
FEMALE
No
Sponsors
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Technical University of Munich
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Fritz Jaenicke, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
References
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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.
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.
Other Identifiers
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GR280/4
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ChemoN0
Identifier Type: -
Identifier Source: org_study_id
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