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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

CMF Chemotherapy

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring node-negative

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

M1 status

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Arm Label

Arm Description

Low uPA/PAI-1: Observation

High uPA/PAI-1: Observation

High uPA/PAI-1: refused randomization

High uPA/PAi-1: CMF chemotherapy

Outcomes

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

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

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

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.

Full Information

NCT ID

NCT01317108

First Posted

February 21, 2011

Last Updated

May 23, 2017

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Technical University of Munich

1. Study Identification

Unique Protocol Identification Number

NCT01317108

Brief Title

Prognostic and Predictive Impact of uPA/PAI-1

Acronym

ChemoN0

Official Title

Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

June 1993 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Technical University of Munich

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

node-negative

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

689 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

Low uPA/PAI-1: Observation

Arm Title

Arm Type

No Intervention

Arm Description

High uPA/PAI-1: Observation

Arm Title

Arm Type

No Intervention

Arm Description

High uPA/PAI-1: refused randomization

Arm Title

Arm Type

Active Comparator

Arm Description

High uPA/PAi-1: CMF chemotherapy

Intervention Type

Drug

Intervention Name(s)

CMF Chemotherapy

Primary Outcome Measure Information:

Title

Prognostic impact of uPA/PAI-1: Number of patients disease-free in low vs. high risk groups according to uPA/PAI-1

Description

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.

Time Frame

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

Title

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

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Overall survival

Description

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.

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: N0 breast cancer patients tumor size >/= 1 and </= 5 cm in diameter undergoing standard loco-regional treatment Exclusion Criteria: M1 status

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fritz Jaenicke, MD

Organizational Affiliation

Universitätsklinikum Hamburg-Eppendorf

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

11416112

Citation

Janicke F, Prechtl A, Thomssen C, Harbeck N, Meisner C, Untch M, Sweep CG, Selbmann HK, Graeff H, Schmitt M; German N0 Study Group. Randomized adjuvant chemotherapy trial in high-risk, lymph node-negative breast cancer patients identified by urokinase-type plasminogen activator and plasminogen activator inhibitor type 1. J Natl Cancer Inst. 2001 Jun 20;93(12):913-20. doi: 10.1093/jnci/93.12.913.

Results Reference

result

PubMed Identifier

23490655

Citation

Harbeck N, Schmitt M, Meisner C, Friedel C, Untch M, Schmidt M, Sweep CG, Lisboa BW, Lux MP, Beck T, Hasmuller S, Kiechle M, Janicke F, Thomssen C; Chemo-N 0 Study Group. Ten-year analysis of the prospective multicentre Chemo-N0 trial validates American Society of Clinical Oncology (ASCO)-recommended biomarkers uPA and PAI-1 for therapy decision making in node-negative breast cancer patients. Eur J Cancer. 2013 May;49(8):1825-35. doi: 10.1016/j.ejca.2013.01.007. Epub 2013 Mar 13.

Results Reference

derived

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Prognostic and Predictive Impact of uPA/PAI-1

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