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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Study on the Potential of Circulating Tumor DNA to Assess the Tumor Response to Neoadjuvant Chemotherapy in Breast Cancer Patients

Conditions
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Circulating Tumor DNA, Breast Cancer, Neoadjuvant Chemotherapy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dynamic changes of plasma ctDNA mutant copies by a panel of 363 cancer-related genes | 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 | From patients recruited into the research until the surgury complete ,assessed up to 26 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival after surgery | 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. | Up to 5 years |