- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01317108
Prognostic and Predictive Impact of uPA/PAI-1 (ChemoN0)
Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0
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:
- 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?
- Do uPA/PAI 1 high-risk patients benefit from adjuvant CMF chemotherapy?
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- N0 breast cancer patients tumor size >/= 1 and </= 5 cm in diameter undergoing standard loco-regional treatment
Exclusion Criteria:
- M1 status
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
DFS at 3, 5, and 10 years (depending on analysis time point)
|
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.
|
DFS at 3, 5, and 10 years (depending on analysis time point)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at 3, 5, and 10 years (depending on analysis time point).
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Fritz Jaenicke, MD, Universitatsklinikum Hamburg-Eppendorf
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChemoN0
- GR280/4 (Other Grant/Funding Number: German Research Association)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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