Circulating microRNA 21 Expression Level Before and After Neoadjuvant Systemic Therapy in Breast Carcinoma

NCT05151224 | Unknown

• 1 other identifier: FMASUMD232/2021
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Carcinoma

Keywords

breast, microRNA 21, Neoadjuvant thera[py

Outcome Measures

Primary Outcomes (1)

• Describe miRNA 21 expression level before and after neoadjuvant systemic therapy in breast cancer patient.

  miRNA 21 expression level before and after neoadjuvant systemic therapy

  1 year

Secondary Outcomes (2)

• Measure relation between miRNA 21 expression level before and after neoadjuvant systemic therapy and pathological response.

  1 year

• Measure relation between the miRNA 21 expression and the clinicopathological parameters of Breast Cancer patients.

  1 year

Study Arms (1)

Breast cancer patients eligible to neoadjuvant systemic therapy

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.

Diagnostic Test: microRNA 21

Interventions

microRNA 21 DIAGNOSTIC_TEST

Plasma microRNA 21 5p expression, by real-time polymerase chain reaction, before and after neoadjuvant systemic therapy. Blood sample will be taken by a trained nurse, amount of blood will be 3 ml, and will be taken twice, one time before the start of the neoadjuvant systemic treatment , second time by the end of the neoadjuvant systemic treatment.

Breast cancer patients eligible to neoadjuvant systemic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Invasive breast cancer, from stage IIB to stage IIIC, all subtypes are included, who are candidates for neoadjuvant systemic therapy.

You may qualify if:

• 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

You may not qualify if:

• Metastatic breast cancer
• inflammatory breast cancer,
• male breast cancer,
• bilateral breast cancer, or concurrent malignancy
• Previous malignancy.
• Presence of any contraindication to neoadjuvant treatment

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

Related Publications (11)

• Mei 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 RESULT

• Yadav 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 RESULT

• Ling 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 RESULT

• Zhang 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 RESULT

• Petrovic 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 RESULT

• Yan 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 RESULT

• Chen 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 RESULT

• Schwarzenbach H. Clinical Relevance of Circulating, Cell-Free and Exosomal microRNAs in Plasma and Serum of Breast Cancer Patients. Oncol Res Treat. 2017;40(7-8):423-429. doi: 10.1159/000478019. Epub 2017 Jun 28.

  PMID: 28683441 RESULT

• Zhu W, Liu M, Fan Y, Ma F, Xu N, Xu B. Dynamics of circulating microRNAs as a novel indicator of clinical response to neoadjuvant chemotherapy in breast cancer. Cancer Med. 2018 Sep;7(9):4420-4433. doi: 10.1002/cam4.1723. Epub 2018 Aug 11.

  PMID: 30099860 RESULT

• Wang H, Tan G, Dong L, Cheng L, Li K, Wang Z, Luo H. Circulating MiR-125b as a marker predicting chemoresistance in breast cancer. PLoS One. 2012;7(4):e34210. doi: 10.1371/journal.pone.0034210. Epub 2012 Apr 16.

  PMID: 22523546 RESULT

• Liu B, Su F, Chen M, Li Y, Qi X, Xiao J, Li X, Liu X, Liang W, Zhang Y, Zhang J. Serum miR-21 and miR-125b as markers predicting neoadjuvant chemotherapy response and prognosis in stage II/III breast cancer. Hum Pathol. 2017 Jun;64:44-52. doi: 10.1016/j.humpath.2017.03.016. Epub 2017 Apr 12.

  PMID: 28412211 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ebtehal M Salah

  Assistant lecturer of clinical oncology

  PRINCIPAL INVESTIGATOR

• Iman Sharawy

  Professor of clinical oncology

  STUDY DIRECTOR

Central Study Contacts

Ebtehal M Salah, MD

CONTACT

+201013678565; ebtehal.mohamed@hotmail.com

Iman A Sharawy, Phd

CONTACT

+201068280224; emansharawy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 27, 2021
• First Posted: December 9, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: December 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)