Carcinogenesis and coagulation activation are closely related processes. In a previous study of coagulation activation in stage I-IIA breast cancer patients, we developed a prognostic model that includes coagulation activation biomarkers and demonstrated efficacy to in distinguish between risk categories and survival. Here, we propose a study useful for the validation of this prognostic model in an independent cohort of 108 patients with locally advanced breast cancer and indicated for neoadjuvant chemotherapy, followed by breast surgery. Within this study population, we will validate our prognostic model for risk assessment and risk stratification with respect to the following endpoints: 1. Complete pathological response rate to definitive breast surgery; 2. Rate of thromboembolic events.
Study Type
OBSERVATIONAL
Enrollment
108
Risk assessment and risk stratification
Policlinico Umberto I
Roma, Italy
RECRUITINGPoliclinico Agostino Gemelli
Roma, Italy
RECRUITING"Regina Elena" National Cancer Institute
Rome, Italy
RECRUITINGPathological response rate
The study will mainly aim to validate the accuracy of previous developed prognostic model in distinguish between risk categories and probabilities of pathological complete response (pCR) detected in patients undergoing neoadjuvant chemotherapy (NACT) and breast surgery.
Time frame: 30 months
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