Breast Cancer, Circulating Tumor DNA, Neoadjuvant Chemotherapy
Conditions
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.
Interventions
None listed
Sponsors
Zhiyong Yu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactZhiyong Yu, PhD
Backup ContactZhaoyun Liu, MD
Outcome results
None listed