Clinical trial NCT03779022: miRNA and Relevant Biomarkers of BC Patients Undergoing Neoadjuvant Treatment
Official title: MicroRNA and Relevant Biomarkers of Breast Cancer in Patients Undergoing Neoadjuvant Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast cancer
biomarker
neoadjuvant treatment
microRNA
response
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female, Breast Cancer, \>18 years,\<75 years, early stage breast cancer patients, with Stage II-III disease

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response
timeFrame: Every 2 cycles, up to surgery (each cycle is 21 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Yimin Cui, Ph.D & M.D
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
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.