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NCT01840306
Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
trial testing Biomarker Analysis in Breast Cancer in 330 participants. Completed in 24 May 2023.
24 May 2023
Quick facts
| Lead sponsor | Cancer Trials Ireland |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 330 |
| Start date | 12 October 2012 |
| Primary completion | 24 May 2023 |
| Estimated completion | 24 May 2023 |
| Sites | 11 locations across Ireland |
Drugs / interventions tested
- Biomarker Analysis
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- HER2 Positive Breast Cancer — all drugs for HER2 Positive Breast Cancer →
- HER2 Negative Breast Cancer — all drugs for HER2 Negative Breast Cancer →
Sponsor
Cancer Trials Ireland — full company profile →
Who can join
18 and older, female only, with Breast Cancer or HER2 Positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary Objective: (i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents, considering clinical responses. (ii) To investigate associations between presence vs. absence (or relative levels) of identified extracellular (EC) RNAs/proteins and patients' clinicopathological characteristics, including age at diagnosis, time to progression and overall survival, as well as correlations with serum protein biomarkers routinely analysed for these patients. (iii) To compare HER2 positive samples versus HER2 negative samples for the existence of RNAs/proteins identified in (i) and (ii). Secondary Objective: To develop a predictive model for use in the HER2 positive population based on the most accurate and sensitive combination of the identified biomarkers.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Protein cargo in extracellular vesicles as the key mediator in the progression of cancer.
Hánělová K, Raudenská M, Masařík M, Balvan J. · · 2024 · cited 60× · PMID 38200509 · DOI 10.1186/s12964-023-01408-6 -
Immune cell-derived exosomal non-coding RNAs in tumor microenvironment: Biological functions and potential clinical applications.
Liu C, Luo Y, Zhou H, Lin M, et al · · 2025 · cited 3× · PMID 40353080 · DOI 10.21147/j.issn.1000-9604.2025.02.10 -
Exosomes in Clinical Laboratory: From Biomarker Discovery to Diagnostic Implementation.
Aljohani MA. · · 2025 · PMID 41303767 · DOI 10.3390/medicina61111930 -
Role of exosomes in cancer: from diagnosis to therapy.
Esparvarinha M, Nickho H, Dashti M, Warkiani ME, et al · · 2025 · PMID 41191232 · DOI 10.1007/s12672-025-03916-y
Verify or expand the search:
- PubMed search for NCT01840306
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01840306 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cancer Trials Ireland
- Last refreshed: 8 July 2025
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/NCT01840306.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing