Examining the impact of metabolic syndrome on breast cancer treatment response

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

This study is testing how metabolic syndrome affects the response to standard breast cancer treatments in patients with advanced forms of the disease to find ways to improve their outcomes.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Roma)
• Trial ID: NCT06261918 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the relationship between metabolic syndrome and the effectiveness of standard therapies in patients with locally advanced breast cancer. By analyzing biological specimens and clinical data, the study seeks to identify new prognostic and predictive biomarkers that could enhance treatment responses. The focus is on patients with Luminal, HER2+, or triple-negative breast cancer, particularly those who may have previously been overlooked due to metabolic factors. The ultimate goal is to improve treatment strategies and patient outcomes through a better understanding of the tumor microenvironment.

Who should consider this trial

Good fit: Ideal candidates for this study are women over 18 years old with locally advanced Luminal, HER2+, or triple-negative breast cancer.

Not a fit: Patients with early-stage breast cancer or those without a diagnosis of metabolic syndrome may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with locally advanced breast cancer.

How similar studies have performed: While there have been studies exploring the relationship between metabolic syndrome and cancer treatment responses, this specific approach focusing on locally advanced breast cancer is relatively novel.

Eligibility criteria

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.

Where this trial is running

Roma

• Fondazione Policlinico Universitario A. Gemelli - IRCCS — Roma, Italy (Recruiting)

Study contacts

• Study coordinator: Alessandra Fabi

Conditions Breast Cancer; Metabolic Syndrome