miRNA and Relevant Biomarkers of BC Patients Undergoing Neoadjuvant Treatment

Breast Cancer Clinical Trial

Official title:

MicroRNA and Relevant Biomarkers of Breast Cancer in Patients Undergoing Neoadjuvant Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03779022
• Other study ID #: miRNA-NAT-BC
• Status: Recruiting
• Start date: November 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2019
• Source: Peking University First Hospital
• Contact: Qian Xiang, Ph.D
• Phone: 86 10 66110802
• Email: xiangqz[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

MicroRNA (miRNA) is a type of endogenous non-coding RNA. They are responsible for post-transcriptional regulation and participate in many vital biological processes. Expression profiling has shown that miRNAs can distinguish between normal breast and tumor tissues. In recent years, circulating miRNAs have become promising biomarkers based on their stability and their non-invasive testing and feasibility in clinical practices.

Description:

Current reports showed that serum microRNA expression could be used as an early marker for determining the breast cancer risk. The concentrations of some circulating microRNAs in human breast cancer have been correlated with tumor development and progression. Aberrant miRNA expression may be involved in drug resistance to various chemotherapeutic agents in breast cancer. Therefore, we hope to investigate the value of miRNAs in predicting the effect in breast cancer neoadjuvant treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Early breast cancer patients;

2. Stage II-III disease;

3. sign informed consent form;

4. receive neoadjuvant treatment;

5. Age between 18-75.

Exclusion Criteria:

1. Women during pregnancy;

2. Metastasis patients or stage IV breast cancer patients;

3. Male breast cancer patients;

4. Inflammatory breast cancer patients;

5. Patients with neoadjuvant endocrine treatment.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• microRNA
The level of microRNA in plasma will be detected by TaqMan in screening phase and by quantitative Real-time PCR (qRT-PCR) in validation phase.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cui Yimin

Country where clinical trial is conducted

China, 

References & Publications (4)

Li Q, Liu M, Ma F, Luo Y, Cai R, Wang L, Xu N, Xu B. Circulating miR-19a and miR-205 in serum may predict the sensitivity of luminal A subtype of breast cancer patients to neoadjuvant chemotherapy with epirubicin plus paclitaxel. PLoS One. 2014 Aug 19;9(8):e104870. doi: 10.1371/journal.pone.0104870. eCollection 2014. Erratum in: PLoS One. 2015;10(8):e0136826. — View Citation

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. — View Citation

Zhao R, Wu J, Jia W, Gong C, Yu F, Ren Z, Chen K, He J, Su F. Plasma miR-221 as a predictive biomarker for chemoresistance in breast cancer patients who previously received neoadjuvant chemotherapy. Onkologie. 2011;34(12):675-80. doi: 10.1159/000334552. Epub 2011 Nov 23. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response	Clinical disease response was evaluated for every two cycles of chemotherapy till surgery with RECIST criteria (RECIST 1.1). Resistant group was defined ad progression disease (PD) and/or stable disease (SD).Evaluation in breast lesions by MRI or mammography. The same imaging methods were used throughout treatment for a given patient. Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery.; Clinical disease response was evaluated for every two cycles of chemotherapy till surgery with RECIST criteria (RECIST 1.1). Evaluation in breast lesions by MRI or mammography. The same imaging methods were used throughout treatment for a given patient.	Every 2 cycles, up to surgery (each cycle is 21 days)