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In nonmetastatic local advanced breast cancer patients, we are going to investigate whether circulating tumor DNA (ctDNA) detection can reflect the tumor response to neoadjuvant chemotherapy (NCT) and detect minimal residual disease after surgery.
Breast cancer is the most common malignant tumor in women worldwide, and chemotherapy is still the main method of breast cancer treatment. And for locally advanced breast cancer patients, neoadjuvant chemotherapy can further improve treatment efficacy, improve prognosis and increase the rate of breast conserving surgery. The persistence of a minimal residual disease at distant sites after the treatment of a localized breast cancer is a key parameter for posttreatment survival but cannot be reliably assessed by the current biological or radiological tools. Therefore, the prediction of the chemotherapy efficacy is very important. ctDNA, corresponds to fragmented DNA released into the blood stream by tumor masses, the detection and quantification of circulating tumor DNA (ctDNA) is a very promising tool that can assess tumor burden, response to therapy, and minimal residual disease. In this study, we wil collect breast cancer cases treated with neoadjuvant chemotherapy, draw blood and evaluate the efficacy each time before chemotherapy and after surgery, then measure the concentration of ctDNA in each sample. We will also analyze the demographic data,basic treatment and follow-up data including relapse, metastasis and survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ctDNA level | ctDNA level during neoadjuant chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ctDNA level during neoadjuant chemotherapy | Other | Draw blood from each enrolled patient every time before chemotherapy and measure the ctDNA level in plasma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The concentration of circulating DNA(ctDNA) | Take the blood each time before chemtherapy and measure the concentration of ctDNA | From date of neoadjuvant chemotherapy decided until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that are considered possible candidates for neoadjuvant chemotherapy, by clinical-pathologic features.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianjun He, PhD | Contact | 0086-13992808259 | chinahjj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianjun He, PhD | First Affiliated Hospital of Xian Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xian Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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tumor biopsy specimen
| D017437 |
| Skin and Connective Tissue Diseases |