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

May 23, 2017 updated by: Universitätsklinikum Hamburg-Eppendorf

Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

689

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • N0 breast cancer patients tumor size >/= 1 and </= 5 cm in diameter undergoing standard loco-regional treatment

Exclusion Criteria:

  • M1 status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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.
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
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.
DFS at 3, 5, and 10 years (depending on analysis time point)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 3, 5, and 10 years (depending on analysis time point).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Technical University of Munich

Investigators

  • Principal Investigator: Fritz Jaenicke, MD, Universitatsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1993

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

February 21, 2011

First Submitted That Met QC Criteria

March 15, 2011

First Posted (Estimate)

March 17, 2011

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChemoN0
  • GR280/4 (Other Grant/Funding Number: German Research Association)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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