Potential of Circulating Tumor DNA to Assess the Tumor Response to Neoadjuvant Chemotherapy in Breast Cancer Patients

• Conditions: Circulating Tumor DNA; Breast Cancer; Neoadjuvant Chemotherapy

• Registration Number: NCT03688035
• Lead Sponsor: Zhiyong Yu

Brief Summary

Breast cancer is the most common malignant tumor in women worldwide,and there exist a large part of patients need to receive neoadjuvant chemotherapy(NAC) before the curative surgery.Circulating tumor DNA(ctDNA) is the circulating free DNA in the blood that originates from cancers,and it can be detected by modern technologies in plasma.In this prospective study,investigators aim to observe the correlation between tumor response to neoadjuvant chemotherapy and ctDNA.

Detailed Description

Women with node-positive breast cancer are at high risk for recurrence. Neoadjuvant chemotherapy is traditionally for locally advanced disease, converting an inoperable tumor to a resectable one.In the present study, investigators will focus on breast cancer patients whose primary tumors are large or have lymph node metastases and need to receive neoadjuvant chemotherapy from 2018 to 2019. Circulating tumor DNA(ctDNA) will be obtained from peripheral blood,and the blood samples will be taken before the neoadjuvant chemotherapy、during the chemotherapy、 before the surgery and post surgery visit (within 24 hours after surgery) .Investigators will collect tissue samples both from the breast lump biopsy and the curative surgery. Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to monitor the efficacy of neoadjuvant chemotherapy in breast cancer.

Study Timeline

• Study First Submitted: 2018-08-30
• Status Verified: 2018-09
• Study Start: 2018-09-20
• Study First Submitted QC: 2018-09-26
• Last Update Submitted: 2018-09-26
• Study First Posted: 2018-09-27
• Last Update Posted: 2018-09-27
• Primary Completion: 2019-09-20
• Study Completion: 2019-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Female patients undergoing neoadjuvant chemotherapy
• Age: 18-70 yrs
• Any menopausal status
• Any hormone receptor status
• Invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy):
• Locally advanced tumor
• Patients who received 6 to 8 cycles of neoadjuvant chemotherapy.

Exclusion Criteria

• Failed to retain blood sample before NAC
• Lost more than 2 blood samples during NAC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
dynamic changes of plasma ctDNA mutant copies by a panel of 363 cancer-related genes	From patients recruited into the research until the surgury complete ,assessed up to 26 weeks.	To assess the changes of ctDNA mutant copies during the process of our observation,and to find out the relationship between ctDNA and tumor response to neoadjuvant chemotherapy

Secondary Outcome Measures

Name	Time	Method
disease free survival after surgery	Up to 5 years	To observe the duration from the end of curative surgery to local recurrence or distant metastasis of breast cancer. Patients were followed up every six months in first three years, then followed up once a year.

Trial Locations

Locations (1)

Shandong Cancer Hospital and Institute; 🇨🇳 Jinan, Shandong, China