ARIAS: Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification
Study Details
Study Description
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:
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Complete pathological response rate to definitive breast surgery;
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Rate of thromboembolic events.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with normal organ functions
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Cytologically/histologically proven breast cancer, stage IIB-IIIC
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Participants must not have prophylactic or therapeutic indications for anticoagulants.
Exclusion Criteria:
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Pregnacy
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Metastatic breast cancer
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Previous chemotherapy, hormone therapy, radiotherapy
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Previous malignancies or contralateral breast cancer
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Policlinico Umberto I | Roma | Italy | 00161 | |
2 | Policlinico Agostino Gemelli | Roma | Italy | 00168 | |
3 | "Regina Elena" National Cancer Institute | Rome | Italy | 00144 |
Sponsors and Collaborators
- Regina Elena Cancer Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RS1307/20