Clinical trial · Observational
PiA: Prognosis Used Every Day for Patients With Operable Breast Cancer - Comparison of Invasion Factors uPA/PAI-1 With Other Prognostic Factors
PiA Trial: a Cross-sectional, Multicenter, Consecutive Cohort Evaluating the Distribution of uPA/PAI-1 Versus St. Gallen Algorithm in >1000 Prospectively Included Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event free survival
- timeFrame
- 2.5 years minimum observation time
- description
- All patients will be followed after a minimum observation time of 2.5 years.
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- 2.5 years
- description
- All patients will be followed after a minimum observation time of 2.5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * newly diagnosed breast cancer * no metastasis detected * operation for breast cancer * female patient * unilateral breast cancer * informed consent given * age min. 18 yrs. Exclusion Criteria: * metastasis of breast cancer * bilateral breast cancer * other cancer within the last 5yrs
References
Publications (3)
- DERIVEDEngel J, Wieder V, Bauer M, Kaufhold S, Stuckrath K, Wilke J, Hanf V, Uleer C, Lantzsch T, Peschel S, John J, Pohler M, Weigert E, Burrig KF, Buchmann J, Santos P, Kantelhardt EJ, Thomssen C, Vetter M. Prognostic and predictive impact of NOTCH1 in early breast cancer. Breast Cancer Res Treat. 2025 Jan;209(1):27-38. doi: 10.1007/s10549-024-07444-1. Epub 2024 Aug 17. PMID 39153127
- DERIVEDBreunig C, Erdem N, Bott A, Greiwe JF, Reinz E, Bernhardt S, Giacomelli C, Wachter A, Kanthelhardt EJ, Beissbarth T, Vetter M, Wiemann S. TGFbeta1 regulates HGF-induced cell migration and hepatocyte growth factor receptor MET expression via C-ets-1 and miR-128-3p in basal-like breast cancer. Mol Oncol. 2018 Sep;12(9):1447-1463. doi: 10.1002/1878-0261.12355. Epub 2018 Jul 30. PMID 30004628
- DERIVEDBernhardt S, Bayerlova M, Vetter M, Wachter A, Mitra D, Hanf V, Lantzsch T, Uleer C, Peschel S, John J, Buchmann J, Weigert E, Burrig KF, Thomssen C, Korf U, Beissbarth T, Wiemann S, Kantelhardt EJ. Proteomic profiling of breast cancer metabolism identifies SHMT2 and ASCT2 as prognostic factors. Breast Cancer Res. 2017 Oct 11;19(1):112. doi: 10.1186/s13058-017-0905-7. PMID 29020998