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Prognostic and Predictive Impact of uPA/PAI-1 (Chemo N0)

This study has been completed.
Sponsor:
Collaborator:
Technische Universität München
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01317108
First received: February 21, 2011
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Drug: CMF Chemotherapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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:
  • Overall survival [ Time Frame: at 3, 5, and 10 years (depending on analysis time point). ] [ Designated as safety issue: No ]
    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.


Enrollment: 689
Study Start Date: June 1993
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317108

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

Publications:

Responsible Party: Prof. Frittz Jänicke, MD, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01317108     History of Changes
Other Study ID Numbers: ChemoN0, GR280/4
Study First Received: February 21, 2011
Last Updated: March 15, 2011
Health Authority: Germany: German Research Foundation

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
node-negative

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013