Actively Recruiting
Transcriptional and Epimetabolic Profile of Breast Carcinoma With Luminal or HER2+ or Locally Advanced Triple-negative Histotype in Patients With/Without Previous Clinical History of Metabolic Syndrome
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-02-15
120
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective pilot study of biological specimens aims to identify new prognostic and predictive biomarkers of response to standard therapy for local advanced BC, as well as to identify new targets for the development of immuno- therapeutic protocols. First aim is therefore to expand our knowledge to increase the response to preoperative treatment, intensify treatment patterns, and select patients based on clinical parameters. In this regard, it appears imperative to investigate yet under-investigated factors that might impair the response to standard therapy for local advanced BC including association to metabolic syndrome and analysis of tumoral and stromal features supporting a tumor microenvironment impenetrable to both drugs and immune system cells.
CONDITIONS
Official Title
Transcriptional and Epimetabolic Profile of Breast Carcinoma With Luminal or HER2+ or Locally Advanced Triple-negative Histotype in Patients With/Without Previous Clinical History of Metabolic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of locally advanced Luminal or HER2+ or Triple negative breast cancer (cT2, T3, T4 N0 or any T N1, N2, N3, M0), clinical stage II to III disease
- Age older than 18 years
- Regular clinical and instrumental follow-up
- Signed informed consent
- Availability of pre/post neoadjuvant chemotherapy blood tests including blood count, glycemia/glycosylated hemoglobin, lipid profile (triglycerides, total cholesterol, HDL and LDL cholesterol)
- Availability of body mass index (BMI) data
- Possible therapy with oral hypoglycaemic drugs/insulin, statins, diuretics/antihypertensive drugs
- Sex hormone hormonal status (pre- or post-menopause)
You will not qualify if you...
- Prior or synchronous history of systemic malignancy
- History of homo- or contralateral breast cancer
- Evidence of metastatic (Stage IV) disease
- Neoadjuvant treatment with hormonal therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli - IRCCS
Roma, Italy
Actively Recruiting
Research Team
A
Alessandra Fabi
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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