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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
Sponsor:
Collaborator:
Technische Universität München
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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.



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Ages Eligible for Study:   18 Years to 65 Years   (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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Technische Universität München
Investigators
Principal Investigator: Fritz Jaenicke, MD Universitätsklinikum Hamburg-Eppendorf