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

Universitätsklinikum Hamburg-Eppendorf

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: CMF Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01317108

ChemoN0

GR280/4 (Other Grant/Funding Number)

Details and patient eligibility

About

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?

Enrollment: 689 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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689 participants in 4 patient groups

A

No Intervention group

Description:

Low uPA/PAI-1: Observation

B2

No Intervention group

Description:

High uPA/PAI-1: Observation

B3

No Intervention group

Description:

High uPA/PAI-1: refused randomization

B1

Active Comparator group

Description:

High uPA/PAi-1: CMF chemotherapy

Treatment:

Drug: CMF Chemotherapy