Circulating Tumor Cell Detection in Patients With Luminal A Breast Cancer
Recruiting · NCT04065321 · Observational (researchers observe without assigning treatment) · Lead sponsor: Shengjing Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The incidence of breast cancer in Chinese women has increased year by year, and luminal A breast cancer commonly occurs in early-stage and postmenopausal women. This type of breast cancer is not sensitive to chemotherapy, although it has a low mortality rate and distant metastasis rate. Studies have shown that luminal A breast cancer is sensitive to endocrine therapy. Patients with breast cancer who undergo excision should be followed up and their prognosis should be monitored regularly. At present, imaging detection is mainly used in the conventional follow-up of breast cancer, but the cost of many imaging examinations is high, so a cost-effective examination is urgently needed. Recent studies have found that circulating tumor cells can be used as a new type of tumor molecular marker, which can be used to diagnose tumors, judge the prognosis and monitor the efficacy by detecting the number and characteristic protein expression of circulating tumor cells. Because circulating tumor cells may develop abnormalities 4-6 months earlier than conventional imaging examination, as long as circulating tumor cells of patients are abnormal, timely PET-CT examination will neither miss diagnosis nor delay the condition. Simultaneously, the cost of hospitalization can be obviously reduced. This non-inferiority randomized controlled clinical trial is designed to compare the differences in postoperative conditions between circulating tumor cell detection and conventional imaging examination in patients with luminal A breast cancer without lymph node metastasis.
Who can take part
Inclusion criteria
- estrogen receptor (≥ 10%), progesterone receptor (≥ 10%) and epidermal growth factor receptor 2 negative;
- proliferation index Ki-67 \< 20%;
- no lymph node metastasis;
- systemic therapy (chemotherapy, radiotherapy and endocrine therapy) in accordance with the National Comprehensive Cancer Network guidelines;
- provision of informed consent of patients and their families.
Exclusion criteria
- Bilateral breast cancer;
- inflammatory breast cancer;
- pregnancy or lactation;
- history of other cancers or chest radiotherapy.
Where it is running
2 locations listed.
- Shengjing Hospital of China Medical University - Shenyang, Liaoning, China
- Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute - Shenyang, Liaoning, China