Clinical trial · Observational
Circulating microRNA 21 Expression Level Before and After Neoadjuvant Systemic Therapy in Breast Carcinoma
NCT05151224CI-TRIAL-00055464unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
MicroRNAs (miRNAs) are involved in the development and progression of malignant tumors. In breast cancer, differential miRNA expression has been demonstrated across breast cancer subtypes, with both tumor-promoting and tumor suppressive functions for individual miRNAs. Novel predictive biomarkers that can be assessed in the liquid specimen before systemic treatment could help to individualize treatment decisions in breast cancer and to potentially avoid ineffective systemic treatment. In our study we detect level of circulating miRNA 21 in breast cancer patient before and after neoadjuvant treatment , whether there will be change or not, and if related to complete pathological response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| microRNA 21 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer patients eligible to neoadjuvant systemic therapy
- description
- Invasive breast cancer, age are 18 years or more, from stage IIB to stage IIIC, all subtypes are included, either HR (ER, PR) positive or negative, HER2 positive or negative, eligible to neoadjuvant systemic therapy.
- interventionNames
- Diagnostic Test: microRNA 21
Primary outcomes (1)
- measure
- Describe miRNA 21 expression level before and after neoadjuvant systemic therapy in breast cancer patient.
- timeFrame
- 1 year
- description
- miRNA 21 expression level before and after neoadjuvant systemic therapy
Secondary outcomes (2)
- measure
- Measure relation between miRNA 21 expression level before and after neoadjuvant systemic therapy and pathological response.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>/= 18 years old. * Breast cancer diagnosis histologically proven and pathology report from breast and ipsilateral axillary nodes. * Pathology: invasive carcinoma. * Staging: tumor size \>2cm (\>/=T2), node positive (N \>/= 1), i.e. \>/= T2N1; from stage IIB to stage IIIC, according to AJCC breast Cancer staging 8th edition. (Giuliano, Edge and Hortobagyi, 2018) * All subtypes are included, either HR (ER, PR) positive or negative, HER2 positive or negative. * Neoadjuvant systemic treatment composed of anthracyclines-based chemotherapy and taxanes, trastuzumab for HER2 positive patients Exclusion Criteria: * Metastatic breast cancer * inflammatory breast cancer, * male breast cancer, * bilateral breast cancer, or concurrent malignancy * Previous malignancy. * Presence of any contraindication to neoadjuvant treatment
References
Publications (11)
- RESULTMei M, Ren Y, Zhou X, Yuan XB, Han L, Wang GX, Jia Z, Pu PY, Kang CS, Yao Z. Downregulation of miR-21 enhances chemotherapeutic effect of taxol in breast carcinoma cells. Technol Cancer Res Treat. 2010 Feb;9(1):77-86. doi: 10.1177/153303461000900109. PMID 20082533
- RESULTYadav P, Mirza M, Nandi K, Jain SK, Kaza RC, Khurana N, Ray PC, Saxena A. Serum microRNA-21 expression as a prognostic and therapeutic biomarker for breast cancer patients. Tumour Biol. 2016 Nov;37(11):15275-15282. doi: 10.1007/s13277-016-5361-y. Epub 2016 Sep 30. PMID 27696295
- RESULTLing H, Fabbri M, Calin GA. MicroRNAs and other non-coding RNAs as targets for anticancer drug development. Nat Rev Drug Discov. 2013 Nov;12(11):847-65. doi: 10.1038/nrd4140. PMID 24172333
- RESULTZhang B, Pan X, Cobb GP, Anderson TA. microRNAs as oncogenes and tumor suppressors. Dev Biol. 2007 Feb 1;302(1):1-12. doi: 10.1016/j.ydbio.2006.08.028. Epub 2006 Aug 16. PMID 16989803
- RESULTPetrovic N. miR-21 Might be Involved in Breast Cancer Promotion and Invasion Rather than in Initial Events of Breast Cancer Development. Mol Diagn Ther. 2016 Apr;20(2):97-110. doi: 10.1007/s40291-016-0186-3. PMID 26891730
- RESULTYan LX, Wu QN, Zhang Y, Li YY, Liao DZ, Hou JH, Fu J, Zeng MS, Yun JP, Wu QL, Zeng YX, Shao JY. Knockdown of miR-21 in human breast cancer cell lines inhibits proliferation, in vitro migration and in vivo tumor growth. Breast Cancer Res. 2011 Jan 10;13(1):R2. doi: 10.1186/bcr2803. PMID 21219636
- RESULTChen L, Bourguignon LY. Hyaluronan-CD44 interaction promotes c-Jun signaling and miRNA21 expression leading to Bcl-2 expression and chemoresistance in breast cancer cells. Mol Cancer. 2014 Mar 8;13:52. doi: 10.1186/1476-4598-13-52. PMID 24606718