Prognostic and Predictive Impact of uPA/PAI-1 (ChemoN0)
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|ClinicalTrials.gov Identifier: NCT01317108|
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : May 25, 2017
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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:
- 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?
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: CMF Chemotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||689 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- N0 breast cancer patients tumor size >/= 1 and </= 5 cm in diameter undergoing standard loco-regional treatment
- M1 status
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317108
|Principal Investigator:||Fritz Jaenicke, MD||Universitätsklinikum Hamburg-Eppendorf|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Universitätsklinikum Hamburg-Eppendorf|
|Other Study ID Numbers:||
GR280/4 ( Other Grant/Funding Number: German Research Association )
|First Posted:||March 17, 2011 Key Record Dates|
|Last Update Posted:||May 25, 2017|
|Last Verified:||March 2011|
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