Evaluation of Treatment Efficacy by Circulating Tumor Cell Phenotype Surveillance in Breast Cancer Patients

Study Overview
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Brief Summary
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The phenotype of circulating tumor cells (CTCs) is supposed to be significant indicator that is correlated the prognosis of breast cancer patients who have completed neoadjuvant chemotherapy, primary tumor surgery with/without adjuvant chemotherapy. The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the prognosis of breast cancer patients.

Detailed Description
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The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the treatment response of neoadjuvant chemotherapy, surgery and adjuvant chemotherapy. This study also aims to evaluate the efficacy of CTCs surveillance in predicting invasive-disease free survival (iDFS), overall survival (OS) and metastasis. Additionally, this study evaluate the expression of PDL1 and FOXC3 on CTCs.

Official Title
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Surveillance of Circulating Tumor Cell Phenotype in Early Stage Breast Cancer Patients With Neoadjuvant Chemotherapy or Adjuvant Chemotherapy

Conditions
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Breast Neoplasms, Neoplastic Cells, Circulating, Chemotherapy Effect

Intervention / Treatment
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* Diagnostic Test: CTC detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria The age is more than 18 years old; Pathology confirmed malignant breast tumor; No clinical diagnosis of other malignancies, unstable complications or uncontrolled infection; Life expectancy is greater than 6 month; The main organ function is normal; The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance. Exclusion Criteria Patients who had suffered from other malignant tumors; With uncontrolled bacterial, viral or fungal infections; With physical or mental disorders Without or limited civil capacity; Infected with human immunodeficiency virus (HIV)； Circumstances in which the investigator considers it inappropriate to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer patients<br> | Diagnostic Test: CTC detection<br>* CTCs separation and enrichment technology. Combined with the prognosis of patients with recurrence and survival time, we explored the evaluation of CTC number, cell phenotype distribution, PDL1 and FOXC2 expression on the prognosis of early stage breast cancer patients. The research results are expected to provide a new effective index and theoretical basis for evaluating the treatment efficacy of breast cancer patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iDFS | The survival time from the date of tumor resection to the date of the relapse of the invasive disease. | From date of enrollment through study completion, up to 10 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | The survival time from the date of recruitment to the date of death. | From date of enrollment through study completion, up to 10 years. | 
| Pathological complete response rate | pCR is defined as no infiltrating tumor cells in pathological examination in the primary breast and axillary lymph nodes. | From date of enrollment up to 24 weeks |