Compliant and Professional

Study Execution

Scientific Scope

 

Phaon aims at …

 

… increasing patient benefit through addressing medical need with selection of effective agents

 

… personalizing therapy through individualized, biomarker-driven treatments concepts that address breast cancer heterogeneity

 

… accelerating drug development through introduction of early study endpoints (including early biological signals and clinical efficacy endpoints)

TitleStatusPhase

BREVITY – Breast Cancer Response Evaluation for Individualized TherapyClosedIn vitro Diagnostic Validation Trial

CountriesCanada, US, Germany, Italy, Ireland
IndicationEarly Breast Cancer
InterventionIn vitro Diagnostic Study
# of sites40
# of patients722
Linkhttp://rnadiagnostics.com/brevity/
PDFhttps://www.clickdimensions.com/links/TestPDFfile.pdf

Rna Diagnostics has initiated an international prospective clinical trial to validate the RNA Disruption Assay™ (RDA™) as a tool for management of primary breast cancer treatment. The goal of the international trial is to define and validate the test's predictive capabilities regarding pathological Complete Response (pCR) at surgery in patients with breast cancer treated with neoadjuvant chemotherapy. One of Phaon's goals is to support translational research fostering the pathway to individualized medicine. We supported this trial from a scientific perspective with Prof. Dr. Kolberg- Liedtke as lead international investigator and PD Dr. Kolberg as head of the protocol board, thereby providing scientific advice from a clinical perspective.

NeoMono - An adaptive randomized neoadjuvant two arm trial in triple-negative breast cancer comparing a mono Atezolizumab window followed by a Atezolizumab - CTX therapy with Atezolizumab – CTX therapySet-UpPhase II

CountriesGermany
IndicationPrimary, treatment naïve triple negative early breast cancer
InterventionDrug Intervention
# of sites40
# of patients458
LinkAbout us
PDFPDF test Link

The NeoMono is a Phaon-Initiated Phase 2 trial, which uses an adaptive bayesian trial design to compare efficacy of neoadjuvant chemotherapy with PDL1-inhibition (Atezolizumab) and Atezolizumab two-week window to chemotherapy with PDL1-inhibition (Atezolizumab). It's translational objective lies in identifying biomarkers predicting (early) response to or resistance against Atezolizumab (alone and with CTX) allowing patients stratification in future clinical trials.