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.
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);
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- 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
- Recruiting
Fondazione Policlinico Universitario A. Gemelli - IRCCS
Roma
Alessandra Fabi, 0630153773, alessandra.fabi@policlinicogemelli.it
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.
- Conditions
- Breast Cancer, Metabolic Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| Patients without metabolic syndrome | Pre/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 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 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.
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)
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.
- First posted15 Feb 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FABI ALESSANDRA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06261918
- Acronym / sponsor ID
- PROMETA / 6269
- Conditions
- Breast Cancer, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without metabolic syndrome | – | Procedure: Influence of metabolic syndrome on the achievement of pathological complete responsePre/postmenopausal patients diagnosed with breast cancer undergoing NCT and subsequent surgery with long follow-up |
| Patients with metabolic syndrome | – | Procedure: Influence of metabolic syndrome on the achievement of pathological complete responsePre/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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pre/postmenopausal patients diagnosed with breast cancer undergoing NCT and subsequent surgery with long follow-up.
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influence of metabolic syndrome on the achievement of pathological complete responseThe 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. | Procedure or surgery | Patients with metabolic syndrome, Patients without metabolic syndrome |
Primary outcome
Acheivement of pathological complete response
Time frame: 36 months
The presence of metabolic syndrome or lifestyle influences the achievement of the full pathological response
1 secondary outcome
Event-free survival (EFS)
Time frame: 36 moths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.