RecruitingNCT06261918

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

120 participants

Start Date

Feb 1, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Metabolic Syndrome

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

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);

Exclusion Criteria3

Prior or synchronous history of systemic malignancy. - History of homo- or contralateral breast cancer.
Evidence of metastatic (Stage IV) disease.
Neo-adjuvant treatment with hormonal therapy.

Interventions

PROCEDUREInfluence of metabolic syndrome on the achievement of pathological complete response

The proposed activity aims to assess the transcriptional and epimetabolic profile of locally advanced luminal or HER2+ or triple negative breast cancer in patients with/without metabolic syndrome to predict the therapeutic response to neoadjuvant chemotherapy.