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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

RECRUITINGSponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Actively Recruiting
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Started2024-02-01
Est. completion2025-02-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

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:

  1. pre/post NAC blood chemistry tests: blood count, glycemia/glycosylated hemoglobin, lipid profile (triglycerides, total cholesterol, HDL + LDL cholesterol);
  2. BMI;
  3. possible therapy with oral hypoglycaemic drugs/insulin; statins; diuretics/antihypertensive drugs;
  4. Sex hormone hormonal status (pre- or post-menopause);

Exclusion Criteria:

* 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.

Conditions3

Breast CancerCancerMetabolic Syndrome

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