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Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0


Phase 3
18 Years
65 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0


Inclusion Criteria:



- N0 breast cancer patients tumor size >/= 1 and standard loco-regional treatment

Exclusion Criteria:

- M1 status

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome 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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Fritz Jaenicke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universit├Ątsklinikum Hamburg-Eppendorf

Authority:

Germany: German Research Foundation

Study ID:

ChemoN0

NCT ID:

NCT01317108

Start Date:

June 1993

Completion Date:

December 2008

Related Keywords:

  • Breast Cancer
  • node-negative
  • Breast Neoplasms

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