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

NCT06261918 | Recruiting

• 1 other identifier: 6269
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Acheivement of pathological complete response

  The presence of metabolic syndrome or lifestyle influences the achievement of the full pathological response

  36 months

Secondary Outcomes (1)

• Event-free survival (EFS)

  36 moths

Study Arms (2)

Patients without metabolic syndrome

Pre/postmenopausal patients diagnosed with breast cancer undergoing NCT and subsequent surgery with long follow-up

Procedure: Influence of metabolic syndrome on the achievement of pathological complete response

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

Procedure: Influence of metabolic syndrome on the achievement of pathological complete response

Interventions

Influence of metabolic syndrome on the achievement of pathological complete response PROCEDURE

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.

Patients with metabolic syndrome; Patients without metabolic syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pre/postmenopausal patients diagnosed with breast cancer undergoing NCT and subsequent surgery with long follow-up.

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli - IRCCS

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Alessandra Fabi

CONTACT

0630153773; alessandra.fabi@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.ssa

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 15, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)