Trials / Completed
CompletedNCT01317108
Prognostic and Predictive Impact of uPA/PAI-1
Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 689 (actual)
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf · Academic / Other
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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?
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CMF Chemotherapy |
Timeline
- Start date
- 1993-06-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2011-03-17
- Last updated
- 2017-05-25
Source: ClinicalTrials.gov record NCT01317108. Inclusion in this directory is not an endorsement.