Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification (ARIAS)

Regina Elena Cancer Institute

Status: Enrolling

Conditions: Local Cancer

Treatments: Other: Prognostic model

Study type: Observational

Funder types: Other

Identifiers

NCT05806632

RS1307/20

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with normal organ functions
• Cytologically/histologically proven breast cancer, stage IIB-IIIC
• Participants must not have prophylactic or therapeutic indications for anticoagulants.

Exclusion criteria

• Pregnacy
• Metastatic breast cancer
• Previous chemotherapy, hormone therapy, radiotherapy
• Previous malignancies or contralateral breast cancer