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Completed

NCT Number: NCT01317108

Prognostic and Predictive Impact of uPA/PAI-1

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?

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • M1 status

Treatment and study plan

CMF Chemotherapy

Drug

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Technical University of Munich

Registry information

Official study title

Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0

Acronym: ChemoN0

Important dates

Study start
1993
Primary completion
2008
Study completion
2008
First posted
Mar 17, 2011
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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