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NCT06261918: PROMETA
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
trial testing Influence of metabolic syndrome on the achievement of pathological complete response in Breast Cancer in 120 participants. Currently enrolling.
1 February 2025
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 1 February 2024 |
| Primary completion | 1 February 2025 |
| Estimated completion | 1 July 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Influence of metabolic syndrome on the achievement of pathological complete response
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
18 and older, female only, with Breast Cancer or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06261918
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06261918 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 15 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06261918.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing