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Breast CancerPROMETANCT06261918

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

An observational study of Breast Cancer and Metabolic Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Metabolic Syndrome
What is being tested?
Influence of metabolic syndrome on the achievement of pathological complete response
Type of treatment
Surgery or procedure
How many people
120 participants
Where
1 siteItaly
Study dates
1 Feb 2024to 1 Jul 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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);
Show all 9Show fewer
  • BMI;
  • possible therapy with oral hypoglycaemic drugs/insulin; statins; diuretics/antihypertensive drugs;
  • Sex hormone hormonal status (pre- or post-menopause);

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting
  • Fondazione Policlinico Universitario A. Gemelli - IRCCS

    Roma

    Alessandra Fabi, 0630153773, alessandra.fabi@policlinicogemelli.it

    Recruiting

Other trials in Italy

About this study

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.

Read the detailed description

Breast cancer (BC) represents the most common cancer disease among women. In Italy, according to the Aiom-Airtum Report "Cancer Numbers 2020," there are an estimated 54,976 new cases in the female population, which represents 30.3 % of all cancers. Although adherence to screening programs has improved in recent years, the diagnosis of locally advanced BC accounts for about 30% of new diagnoses.

Neo-adjuvant therapy (NCT), which is the administration of chemotherapy drugs combined with biologic therapies if indicated, is the gold-standard in the setting of patients with locally advanced BC (1). It allows down-staging of the primary neoplasm so that conservative rather than demolitive surgical treatment can be performed. NCT also allows prognostic evaluation based on the response obtained to the treatment itself. Noteworthy, a large meta-analysis conducted on 11955 patients enrolled in 12 different clinical trials reported a significant correlation between obtaining a pathological complete response (pathological complete response, pCR, i.e., absence of invasive disease in both breast and lymph nodes) and both event-free survival (EFS) and overall survival (OS) in all tumor subtypes, albeit more pronounced for HER-2 positive neoplasms (EFS: HR 0. 39, CI 95% 0.31-0.50; OS: HR 0.34, CI 95% 0.24-0.47) or triple negative (EFS: HR 0.24, CI 95% 0.18-0.33; OS: HR 0.16, CI 95% 0.11-0.25) (2). To date, about 30% of BC patients go on to pCR following NCT (2), thus highlighting the need for further investigation to expand the proportion of these patients who may benefit from long-lasting clinical responses following such therapy. The consideration of a preexisting history of metabolic syndrome might open new avenues in therapeutic and prognostic perspectives.

Despite the numerous drugs currently available for the NCT, classic chemotherapy (CT) represents the most widely used class of drugs. Growing pieces of evidence show that the efficacy of CT depends not only on its ability to directly inhibit or kill malignant cells, but also on features of the tumor microenvironment in term of metabolic alterations, which might influence the anti-tumoral response (3). Specifically, tumor cell death promoted by cytotoxic drugs causes the release of cancer-associated antigens that, in turn, activate and recruit immune cells within the tumor (4). A recent Italian phase 2 study, the GIADA trial, showed that the number of tumor-infiltrating lymphocytes is significantly associated with pCR and that anthracycline-based chemotherapy treatment results in the establishment of a more immunogenic tumor microenvironment (5). Early results show that despite an improvement in pCR, a considerable number of treated individuals still do not respond or lack long-term responses (6). This evidence suggests that such combinatorial regimens often fail to neutralize all of the immunosuppressive activities that BC enacts to resist CT, evade the anti-tumor immune response, and progress (7). To date, the identification of a system that can predict responses to NCT and the delineation of mechanisms of immunosuppressive resistance in patients with BC unresponsive to NCT remain unresolved issues.

The complex network of interactions between immune cells and other components of the tumor microenvironment results in significant heterogeneity in clinical practice to the response to precision medicine therapeutic options. Consequently, it will be increasingly important to decipher the functional status of the metabolic status of the tumor microenvironment in each patient in order to move from standardized therapy to individualized treatment that in the future could increase survival and improve the quality of life of a greater numbers of BC patients.

Being tested
Influence of metabolic syndrome on the achievement of pathological complete response
Medical subject headings
Breast Neoplasms, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Influence of metabolic syndrome on the achievement of pathological complete responseProcedure or surgery

    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.

Study groups in NCT06261918
Study groupRoleWhat they receive
Patients without metabolic syndromePre/postmenopausal patients diagnosed with breast cancer undergoing NCT and subsequent surgery with long follow-up
Receives: Procedure: Influence of metabolic syndrome on the achievement of pathological complete response
Patients with metabolic syndromePre/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
Receives: Procedure: Influence of metabolic syndrome on the achievement of pathological complete response

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acheivement of pathological complete response

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

    Measured: 36 months

Secondary outcomes (1)
  1. Event-free survival (EFS)

    The presence of metabolic syndrome or lifestyle can reduce the development of cancer recurrence

    Measured: 36 moths

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2024
  2. Study start1 Feb 2024
  3. Primary completion1 Feb 2025 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06261918
Sponsor's protocol ID
6269
Acronym
PROMETA
Status last verified
Feb 2024
First submitted
8 Feb 2024
Last updated
15 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Metabolic Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alessandra Fabi (0630153773, alessandra.fabi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acheivement of pathological complete response (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.

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