miRNA and Relevant Biomarkers of BC Patients Undergoing Neoadjuvant Treatment

• Conditions: Breast Cancer
• Interventions: Genetic: microRNA

• Registration Number: NCT03779022
• Lead Sponsor: Cui Yimin

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.

Study Timeline

• Study Start: 2015-11-01
• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-16
• Study First Posted: 2018-12-19
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Resistant	microRNA	Resistant group was defined ad progression disease (PD) and/or stable disease (SD). Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery.
Sensitive	microRNA	Sensitive group was defined ad complete response (CR) and/or partial response (PR). Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery.

Primary Outcome Measures

Name	Time	Method
Objective Response	Every 2 cycles, up to surgery (each cycle is 21 days)	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.

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China