PiA: Prognosis Used Every Day for Patients With Operable Breast Cancer - Comparison of Invasion Factors uPA/PAI-1 With Other Prognostic Factors
Recruitment status was Active, not recruiting
The improvement of the healing rates for breast cancer is based to an important part on the consistent use of so-called adjuvant ("supporting ") medicamentous therapies, including chemotherapy. However this success has a price due to still inaccurate knowledge of the individual risk of relapse: a high number of unnecessary therapies are applied (over-therapy!). The invasion factors uPA (plasminogen activator of the urokinase type) and PAI-1 (uPA inhibitor) were described extensively as strong and independent prognosis factors with high clinical relevance for patients with node negative breast cancer. Compared to clinical and pathological factors (further: "traditional factors ") they show better estimation of the relapse risk leading to an avoidance of redundant adjuvant chemotherapy and may thus essentially contribute to the improvement of the quality of life in these women. In this study we aim to evaluate, how large the portion of the patients with early, operable, node negative breast cancer will be, in whom, by improved low-risk identification through uPA/PAI-1, adjuvant chemotherapy can be omitted.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||PiA Trial: a Cross-sectional, Multicenter, Consecutive Cohort Evaluating the Distribution of uPA/PAI-1 Versus St. Gallen Algorithm in >1000 Prospectively Included Patients|
- Event free survival [ Time Frame: 2.5 years minimum observation time ] [ Designated as safety issue: No ]All patients will be followed after a minimum observation time of 2.5 years.
- Overall survival [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]All patients will be followed after a minimum observation time of 2.5 years
Biospecimen Retention: Samples With DNA
Tumor specimen frozen Tumor specimen formalin fixed
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||September 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592825
|Principal Investigator:||Eva J Kantelhardt, MD||Gynecology Martin Luther Univ Halle/Germany|