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

Central South University

Status: Enrolling

Conditions: Chemotherapy Effect; Breast Neoplasms; Neoplastic Cells, Circulating

Treatments: Diagnostic Test: CTC detection

Study type: Observational

Funder types: Other

Identifiers

NCT05326295

KYJJ-2021-186

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

1,000 participants in 1 patient group

Breast cancer patients

Treatment:

Diagnostic Test: CTC detection