Local Cancer
Conditions
Brief summary
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.
Interventions
OTHERPrognostic model
Risk assessment and risk stratification
Sponsors
Regina Elena Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological response rate | 30 months | 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. |
Countries
Italy
Contacts
Primary ContactPatrizia Vici, MD
Backup ContactMaddalena Barba, MD
Outcome results
None listed