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| ID | Type | Description | Link |
|---|---|---|---|
| GR280/4 | Other Grant/Funding Number | German Research Association |
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| Name | Class |
|---|---|
| Technical University of Munich | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | No Intervention | Low uPA/PAI-1: Observation | |
| B2 | No Intervention | High uPA/PAI-1: Observation | |
| B3 | No Intervention | High uPA/PAI-1: refused randomization | |
| B1 | Active Comparator | High uPA/PAi-1: CMF chemotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMF Chemotherapy | Drug |
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| 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 | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fritz Jaenicke, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11416112 | Result | 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. | |
| 23490655 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Derived |
| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |