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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
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∙ Patients will be treated as per standard. Inclusion criteria depend exclusively on compliance with informed consent, tumor size (only advanced stage tumors will be used for the study) and histological diagnosis. Specifically, patients with the following will be included in the proposed study:

• 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 \> 18 years

• Regular clinical and instrumental follow up

• Informed consent form signed by enrolled patients - Availability of information from medical records:

‣ pre/post NAC blood chemistry tests: blood count, glycemia/glycosylated hemoglobin, lipid profile (triglycerides, total cholesterol, HDL + LDL cholesterol);

⁃ BMI;

⁃ possible therapy with oral hypoglycaemic drugs/insulin; statins; diuretics/antihypertensive drugs;

⁃ Sex hormone hormonal status (pre- or post-menopause);

Locations
Other Locations
Italy
Fondazione Policlinico Universitario A. Gemelli - IRCCS
RECRUITING
Roma
Contact Information
Primary
Alessandra Fabi
alessandra.fabi@policlinicogemelli.it
0630153773
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 120
Treatments
Patients without metabolic syndrome
Pre/postmenopausal patients diagnosed with breast cancer undergoing NCT and subsequent surgery with long follow-up
Patients with metabolic syndrome
Pre/postmenopausal patients diagnosed with breast cancer undergoing NCT and subsequent surgery with long follow-up~Metabolic syndrome evaluated on the basis of the following criteria:~1. BMI≥30~2. Glycosylated hemoglobin/baseline blood glucose~3. Triglycerides~4. Hypertension~5. Lipid profile
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov

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