Circulating Tumor Cell Detection in Patients With Luminal A Breast Cancer

NCT ID: NCT04065321

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2029-09-30

Brief 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.

Detailed 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.

Conditions

Breast Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control group

250 patients will be assigned into control group.

PET-CT examination

Intervention Type: PROCEDURE

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.

Trial group

250 patients will be assigned into trial group.

Peripheral blood detection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jianyi Li

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianyi Li, MD

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Locations

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianyi Li

Role: CONTACT

sjbreast@yeah.net

+8618940257177

Facility Contacts

Jianyi Li, MD

Role: primary

sjbreast@yeah.net

8618940257177

Jianyi Li, Dr.

Role: primary

sjbreast@yeah.net

13390127607

Other Identifiers

Shengjing-LJY04

Identifier Type: -

Identifier Source: org_study_id