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

• ClinicalTrials.gov Identifier: NCT01317108
• Recruitment Status: Completed
• First Posted: March 17, 2011
• Last Update Posted: May 25, 2017
• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborator: Technical University of Munich
• Information provided by (Responsible Party): Universitätsklinikum Hamburg-Eppendorf

Tracking Information

• First Submitted Date: February 21, 2011
• First Posted Date: March 17, 2011
• Last Update Posted Date: May 25, 2017
• Study Start Date: June 1993
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 15, 2011)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 15, 2011)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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:

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?

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Breast Cancer
• Intervention: Drug: CMF Chemotherapy

Study Arms

• No Intervention: A
  Low uPA/PAI-1: Observation
• No Intervention: B2
  High uPA/PAI-1: Observation
• No Intervention: B3
  High uPA/PAI-1: refused randomization
• Active Comparator: B1
  High uPA/PAi-1: CMF chemotherapy
  Intervention: Drug: CMF Chemotherapy

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 15, 2011): 689
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2008
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01317108
• Other Study ID Numbers: ChemoN0; GR280/4 ( Other Grant/Funding Number: German Research Association )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Universitätsklinikum Hamburg-Eppendorf
• Original Responsible Party: Prof. Frittz Jänicke, MD, Universitätsklinikum Hamburg-Eppendorf
• Current Study Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Original Study Sponsor: Same as current
• Collaborators: Technical University of Munich

Investigators

• Principal Investigator: Fritz Jaenicke, MD; Universitätsklinikum Hamburg-Eppendorf

• PRS Account: Universitätsklinikum Hamburg-Eppendorf
• Verification Date: March 2011