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

Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification in Reference to Patient Important Outcomes for Locally Advanced Breast Cancer: The ARIAS Trial

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 Overview

• Status: Recruiting
• Conditions: Local Cancer
• Intervention / Treatment: Other: Prognostic model

• Study Type: Observational
• Enrollment (Anticipated): 108

Contacts and Locations

• Study Contact: Name: Patrizia Vici, MD; Phone Number: +39 06 52665698; Email: patrizia.vici@ifo.gov.it
• Study Contact Backup: Name: Maddalena Barba, MD; Phone Number: +39 0652665419; Email: maddalena.barba@ifo.gov.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Policlinico Agostino Gemelli
    • Contact: Paola Cassano
  • Roma, Italy, 00161
    • Recruiting
    • Policlinico Umberto I
    • Contact: Paolo Marchetti
  • Rome, Italy, 00144
    • Recruiting
    • "Regina Elena" National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with stage IIB-IIIC breast cancer undergoing neoadjuvant chemotherapy (NACT), followed by breast surgery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological 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.	30 months

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Actual): December 22, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RS1307/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No