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Prognostic and Predictive Impact of uPA/PAI-1 (ChemoN0)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01317108
First Posted: March 17, 2011
Last Update Posted: May 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Technische Universität München
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0

Resource links provided by NLM:


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) ]
    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.


Secondary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01317108     History of Changes
Other Study ID Numbers: ChemoN0
GR280/4 ( Other Grant/Funding Number: German Research Association )
First Submitted: February 21, 2011
First Posted: March 17, 2011
Last Update Posted: May 25, 2017
Last Verified: March 2011

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
node-negative

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