Trial | NCT01317108  Report issue

Title

Prognostic and Predictive Impact of uPA/PAI-1
Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    689
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?
Study Started
Jun 30
1993
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2008
Last Update
May 25
2017

Drug CMF Chemotherapy

A No Intervention

Low uPA/PAI-1: Observation

B2 No Intervention

High uPA/PAI-1: Observation

B3 No Intervention

High uPA/PAI-1: refused randomization

B1 Active Comparator

High uPA/PAi-1: CMF chemotherapy

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

M1 status
No Results Posted