Circulating Tumor Cell Detection in Patients With Luminal A Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Effect of Circulating Tumor Cell Detection in Patients With Luminal A Breast Cancer Without Lymph Node Metastasis Instead of Conventional Imaging Examination After Operation: a Non-Inferiority Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04065321
• Other study ID #: Shengjing-LJY04
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: September 30, 2029

Study information

• Verified date: May 2022
• Source: Shengjing Hospital
• Contact: Jianyi Li
• Phone: +8618940257177
• Email: sjbreast[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Breast cancer ranks first in the incidence of female malignant tumors and second in mortality. It is mainly classified into luminal A, luminal B, human epidermal growth factor receptor 2 positive, basal-like and other special types of breast cancer. Epidemiological studies have shown that the incidence of luminal A breast cancer is 44.5-69.0%, mostly in early-stage patients and postmenopausal women, with a low mortality rate and distant metastasis rate. Luminal A breast cancer is usually invasive. Although it is not sensitive to chemotherapy, luminal A breast cancer is sensitive to endocrine therapy. Therefore, the treatment of luminal A breast cancer is a combination of surgery, chemotherapy, radiotherapy and endocrine therapy.

After surgical removal of breast cancer, follow-up should be conducted according to the National Comprehensive Cancer Network guidelines to monitor the prognosis at any time. Conventional follow-up is mainly based on imaging examination, but the cost of many imaging examinations is high, so a cost-effective examination is urgently needed.

Circulating tumor cells are tumor cells that fall off from solid tumors (primary and metastatic foci) and enter the peripheral blood. In recent 30 years, circulating tumor cells have become one of the new tumor molecular markers. Detection of the number and protein expression of circulating tumor cells can diagnose the disease, judge the prognosis and monitor the therapeutic effect. Epithelial-mesenchymal transition and overexpression of epithelial cell adhesion molecule in circulating tumor cells suggest that the prognosis of cancer patients is not good. By comparing the number of circulating tumor cells in blood before and after surgery or radiotherapy and chemotherapy,whether the treatment is effective or not can be judged, which has important clinical research and application value. Currently, many clinical trials have used circulating tumor cells to monitor the prognosis in breast cancer. Circulating tumor cells may develop abnormalities 4-6 months earlier than conventional imaging examination, and PET-CT can only find subclinical lesions 4-6 weeks in advance. Thus, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 30, 2029
• Est. primary completion date: September 30, 2024
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplastic Cells, Circulating

Intervention

Procedure:
• PET-CT examination
All patients in the control group will undergo PET-CT examination after operation, and will reexamination once every 4 months in 2 years, every 6 months in 3-5 years, and every year in more than 5 years.
• Peripheral blood detection
All patients in the trial group will be followed up after operation, and will reexamination once every 4 months in 2 years, every 6 months in 3-5 years, and every year in more than 5 years. Peripheral blood will be collected for detection of circulating tumor cells at each follow-up. If circulating tumor cells are abnormal (number of circulating tumor cells = 2 or CD133 = 1), PET-CT will be performed immediately.

Locations

Country	Name	City	State
China	Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total length of hospital stay	Total length of hospital stay for patients during the reexamination	5 years
Other	Average length of hospital stay per reexamination	Average length of hospital stay per reexamination = total length of hospital stay/number of reexaminations	5 years
Other	Total cost of reexaminations	Total cost of all reexaminations, including medical insurance and other insurance reimbursements	5 years
Other	Average cost per reexamination	Average cost per reexamination = total cost of reexaminations/number of reexaminations	5 years
Primary	Disease-free survival	Disease-free survival refers to the period from breast cancer excision to local recurrence, distant metastasis confirmed by clinical evidence, diagnosis of the second primary tumor or death of the patient.	5 years
Secondary	Overall survival	Overall survival refers to the time from breast cancer excision to death due to any cause	5 years